OTTO BOCK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-08-25 for OTTO BOCK manufactured by .

Event Text Entries

[20218434] I received an otto block c-leg around the first of this year. It did not feel right and did not act to the specs in the users guide. I reported this to the prosthetist and he advised me "you don't know what you are doing. Keep wearing it. Then around march, the knee completely locked up. I returned the prosthetic device to company. The device was returned to the manufacturer. It was reported that a servo was bad and shorted the battery causing the problem. In the mean time i tried to contact otto block directly by email and got a response from a mfr's rep, and she advised me the problem was between the prosthetist and you. "your knee -- your problem". How can a foreign country based company do business like this in the u. S.? I received the c-leg back and it still did not want to act right. The knee collapsed on me, causing me to almost fall, spilling hot coffee on myself. On the second occasion, the knee caused me to almost fall down a flite of stairs. I reported this to the prosthetist and he advised me to return it, and i did as requested. I was advised the hydraulics went out and the knee returned. The knee became unstable again and did not function properly. I also tried to contact co's rep twice. Calls were not returned. I tried to call mfr direct and was given a runaround. Is this how these companies can operate? The knee failed for the third time. I returned it to the prosthetics company and requested a refund. I was advised no! By the prosthetist. What he advised was basically "otto block or wheelchair!! No inbetween!! I have been fighting with this for eight months now without resolve. The prosthetic company has my prosthetic leg and the accessories. I think otto block is behind this. I am finding out that prosthetics are not regulated as far as safety goes. How does a company get to put a product on the market without properly training not only the prosthetist, but therapist as well. Then update training every year. Medical professional must go through continuous training every year. How is this group left out? These companies are refusing to give out general information. How can they get away with this? Please check and advise.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5012538
MDR Report Key1455980
Date Received2009-08-25
Date of Report2009-08-25
Date Added to Maude2009-09-03
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameOTTO BOCK
Generic NameC-LEG
Product CodeISS
Date Received2009-08-25
Model NumberNA
Device AvailabilityN
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2009-08-25

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