C-LEG KNEE JOINT 3C88-1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-08-01 for C-LEG KNEE JOINT 3C88-1 manufactured by Otto Bock Healthcare Products Gmbh.

Event Text Entries

[15103308] The pt fell because the knee became free (unlocked). Left hip pain occurred.
Patient Sequence No: 1, Text Type: D, B5


[15477303] No errors occurred during incoming inspection, all tests were passed. After evaluating the errors logged in the knee joint the valve responsible for controlling stance phase damping seemed to have positioning problems. One part of the servo unit was identified to bear some unintended coating on its surface, which could have caused the positioning problems.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9615892-2014-00008
MDR Report Key4121943
Report Source08
Date Received2014-08-01
Date of Report2014-07-31
Date of Event2014-06-12
Date Mfgr Received2014-07-01
Device Manufacturer Date2009-01-01
Date Added to Maude2014-10-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactREINHARD WOLKERSTORFER
Manufacturer StreetKAISERSTRASSE 39
Manufacturer CityWIEN 1070
Manufacturer CountryAU
Manufacturer Postal1070
Manufacturer Phone3152337866
Single Use3
Remedial ActionRP
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameC-LEG KNEE JOINT
Generic NameEXTERNAL ABOVE KNEE PROSTHESIS
Product CodeISW
Date Received2014-08-01
Model Number3C88-1
OperatorLAY USER/PATIENT
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerOTTO BOCK HEALTHCARE PRODUCTS GMBH
Manufacturer AddressVIENNA AU


Patients

Patient NumberTreatmentOutcomeDate
10 2014-08-01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.