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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE PRODUCTS GMBH KENEVO; EXTERNAL ABOVE KNEE PROSTHESIS
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OTTO BOCK HEALTHCARE PRODUCTS GMBH KENEVO; EXTERNAL ABOVE KNEE PROSTHESIS Back to Search Results
Model Number 3C60=ST
Device Problem Device Handling Problem (3265)
Patient Problems Contusion (1787); Fall (1848)
Event Date 06/05/2019
Event Type  Injury  
Manufacturer Narrative
Device evaluation in progress; supplemental report will be submitted after additional information has been obtained.
 
Event Description
Wrong knee joint behavior.Knee joint beeps permanently.Patient fell.
 
Manufacturer Narrative
Evaluation and investigation of the device showed no relevant error which may have caused or contributed to the occurred event.Due to certification issues (webtrader) this report will be submitted once access is restored.(see (b)(4) e-mail conversation with cdrh emdr from 2019-08-08).
 
Event Description
Wrong knee joint behavior.Knee joint beeps permanently even after connection to the charger! patient fell.
 
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Brand Name
KENEVO
Type of Device
EXTERNAL ABOVE KNEE PROSTHESIS
Manufacturer (Section D)
OTTO BOCK HEALTHCARE PRODUCTS GMBH
brehmstrasse 16
vienna, 1110
AU  1110
MDR Report Key8770414
MDR Text Key150363364
Report Number9615892-2019-00010
Device Sequence Number1
Product Code ISY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 06/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number3C60=ST
Device Catalogue Number3C60=ST
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2019
Date Manufacturer Received07/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age83 YR
Patient Weight58
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