Aug 17, 2017 19:31
6 yrs ago
German term
Germany
Medical Doctor and Translator
Native in: English 
Works in: Japanese to English, German to English, Dutch to English, and 3 more.
Mutmaßung
German to English
Medical
Medical: Instruments
FDA Medical Device Reporting
Hi all!
I have a question about FDA Medical Device Reporting. The document I am working on states that there are three types of incidents, of which a Mutmaßung is one (definition from the document: Das Medizinprodukt könnte zu einer potentiell tödlichen oder schwerwiegenden Verletzung führen.)
I have tried searching the FDA MDR site, but I am unable to find the exact translation of the terms for incident classification - perhaps someone can assist?
Any help will be appreciated!
Thanks,
Sarai
I have a question about FDA Medical Device Reporting. The document I am working on states that there are three types of incidents, of which a Mutmaßung is one (definition from the document: Das Medizinprodukt könnte zu einer potentiell tödlichen oder schwerwiegenden Verletzung führen.)
I have tried searching the FDA MDR site, but I am unable to find the exact translation of the terms for incident classification - perhaps someone can assist?
Any help will be appreciated!
Thanks,
Sarai
Proposed translations
(English)
| 3 +2 | presumption/assumption |
David Hollywood
|
| 3 | suspected risks |
Michael Martin, MA
|
| 3 | reasonable suggestion |
Johanna Timm, PhD
|
Proposed translations
+2
35 mins
David Hollywood
Native in English
worked for int. orgs (IMF, OAS, IDB)
Native in: English
Works in: Spanish to English, German to English
Related KudoZ points
:
45
Selected
presumption/assumption
Das Medizinprodukt könnte zu einer potentiell tödlichen oder schwerwiegenden Verletzung führen.
The medical product/device could lead to a potentially fatal or serious injury.
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Note added at 1 hr (2017-08-17 21:16:19 GMT)
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An MDR guidance for manufacturers issued in 1997 stated that once a malfunction has caused or contributed to a death or serious injury, a presumption that the malfunction is likely to cause or contribute to a death or serious injury has been established.
The medical product/device could lead to a potentially fatal or serious injury.
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Note added at 1 hr (2017-08-17 21:16:19 GMT)
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An MDR guidance for manufacturers issued in 1997 stated that once a malfunction has caused or contributed to a death or serious injury, a presumption that the malfunction is likely to cause or contribute to a death or serious injury has been established.
Peer comment(s):
| agree |
Kim Metzger
11 mins
|
|
thanks Kim and I also like Phil's "suspicion" from another of Sarai's questions
|
|
| agree |
Lancashireman
: ... // Always pleased to support a reasonable suggestion :-)
22 mins
|
|
thanks L and appreciate it from a top translator of your calibre (and I mean that seriously)
|
4 KudoZ points awarded for this answer.
Comment: "Selected automatically based on peer agreement."
1 hr
Michael Martin, MA
United States
United States
Native in German
&
English
United States
Creativity wins in the long run
Native in: German (Variant: Germany) 
, English (Variant: US)
Works in: German to English
Related KudoZ points
:
18
suspected risks
Suspected risks associated with medical devices?
I don't think you would use an isolated noun or verb-turned-noun in the first place. That's often done in German but doesn't work really well in English.
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Note added at 1 hr (2017-08-17 20:56:03 GMT)
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"An employee of the organization has received information that gives rise to the suspicion that an undesired event has occurred that needs to be reported."
I don't think you would use an isolated noun or verb-turned-noun in the first place. That's often done in German but doesn't work really well in English.
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Note added at 1 hr (2017-08-17 20:56:03 GMT)
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"An employee of the organization has received information that gives rise to the suspicion that an undesired event has occurred that needs to be reported."
21 hrs
Johanna Timm, PhD
Canada
Canada
Native in German
Canada
Friendly, fast & certified!
Native in: German (Variants: Swiss, Platt / Nieder (Low German), Austrian, Germany)
Works in: English to German, German to English, German
Related KudoZ points
:
40
reasonable suggestion
Bekanntwerden: becoming aware of
Mutmaßung- reasonable suggestion
Under the MDR regulation, “MDR reportable events” are events that manufacturers become aware of that reasonably suggest that one of their marketed devices may have caused or contributed to a death or serious injury, or has malfunctioned and the malfunction of the device or a similar device that they market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.”
https://www.lexology.com/library/detail.aspx?g=6fb9473f-3d1d...
A further review of this Case file revealed that a Medical Event Non-Reportable evaluation was completed on or about 1108/27 /2008" which states. After reviewing the case, it has been determined there is no reasonable suggestion of serious injury or device malfunction.
www.fdanews.com/ext/resources/files/archives/a/Abbott.pdf
Specifically, the manufacturer must investigate and report to the FDA all serious or life-threatening adverse events about which it becomes aware if there is a reasonable suggestion that the manufacturer’s device may have caused or contributed to such events.
www.michigan.gov/documents/mdch/Rapid_Flu_testingNov2012_40...
or google: “reasonable suggestion” medical device reporting
Mutmaßung- reasonable suggestion
Under the MDR regulation, “MDR reportable events” are events that manufacturers become aware of that reasonably suggest that one of their marketed devices may have caused or contributed to a death or serious injury, or has malfunctioned and the malfunction of the device or a similar device that they market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.”
https://www.lexology.com/library/detail.aspx?g=6fb9473f-3d1d...
A further review of this Case file revealed that a Medical Event Non-Reportable evaluation was completed on or about 1108/27 /2008" which states. After reviewing the case, it has been determined there is no reasonable suggestion of serious injury or device malfunction.
www.fdanews.com/ext/resources/files/archives/a/Abbott.pdf
Specifically, the manufacturer must investigate and report to the FDA all serious or life-threatening adverse events about which it becomes aware if there is a reasonable suggestion that the manufacturer’s device may have caused or contributed to such events.
www.michigan.gov/documents/mdch/Rapid_Flu_testingNov2012_40...
or google: “reasonable suggestion” medical device reporting
Discussion
"Event Type: Injury"
Are the 3 terms perhaps *reasons* for submitting an incident report?
I really appreciate all of your feedback and will definitely make a post after the final readthrough! Thanks again for the great input!
Without more context, presumption/assumption sounds too strong. The language used in 2.1 says 'may have caused/contributed', or 'is likely to cause/contribute.' I believe the presumption/assumption about the safety of FDA approved medical devices is that they are safe, until proven otherwise.
'Mutmassung' on its own is weaker than presumption/assumption; it's more in the sense of conjecture, speculation (see www.leo.org).
Good luck!