Mutmaßung

English translation: presumption/assumption

19:31 Aug 17, 2017
German to English translations [PRO]
Medical - Medical: Instruments / FDA Medical Device Reporting
German term or phrase: Mutmaßung
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
Dr Sarai Pahla, MBChB
Germany
Local time: 09:27
English translation:presumption/assumption
Explanation:
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.
Selected response from:

David Hollywood
Local time: 05:27
Grading comment
Selected automatically based on peer agreement.
4 KudoZ points were awarded for this answer



Summary of answers provided
3 +2presumption/assumption
David Hollywood
3suspected risks
Michael Martin, MA
3reasonable suggestion
Johanna Timm, PhD


Discussion entries: 13





  

Answers


1 hr   confidence: Answerer confidence 3/5Answerer confidence 3/5
suspected risks


Explanation:
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."

Michael Martin, MA
United States
Local time: 04:27
Native speaker of: Native in GermanGerman, Native in EnglishEnglish
PRO pts in category: 18
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35 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +2
presumption/assumption


Explanation:
Das Medizinprodukt könnte zu einer potentiell tödlichen oder schwerwiegenden Verletzung führen.

The medical product/device could lead to a potentially fatal or serious injury.

--------------------------------------------------
Note added at 1 hr (2017-08-17 21:16:19 GMT)
--------------------------------------------------

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.

David Hollywood
Local time: 05:27
Native speaker of: English
PRO pts in category: 45
Grading comment
Selected automatically based on peer agreement.

Peer comments on this answer (and responses from the answerer)
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)
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21 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
reasonable suggestion


Explanation:
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



Johanna Timm, PhD
Canada
Local time: 01:27
Native speaker of: Native in GermanGerman
PRO pts in category: 40
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