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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=RL-DE
Device Problem Device Handling Problem (3265)
Patient Problems Fall (1848); Bone Fracture(s) (1870)
Event Date 09/28/2019
Event Type  Injury  
Manufacturer Narrative
Device evaluation in progress; supplemental report will be submitted after additional information has been obtained.
 
Event Description
Patient fell with loaner.Wrong joint behavior, sporadically no stance phase resistance when walking on flat surface sudden failure of stance phase damping during walking on (b)(6) 2019, our patient m., p.Crashed around 14:45 o'clock in the hallway of his apartment and got injured femoral neck fracture on the prosthesis side.His wife reported "that he probably fell suddenly while walking." within a conversation on (b)(6) 2019 with her and the signer, it was not determined how exactly the fall was going on.
 
Manufacturer Narrative
Evaluation and investigation of the device showed no relevant error which may have caused or contributed to the occurred event.
 
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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 Key9233213
MDR Text Key173062290
Report Number9615892-2019-00016
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 09/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number3C60=RL-DE
Device Catalogue Number3C60=RL-DE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2019
Date Manufacturer Received11/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age60 YR
Patient Weight75
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