C-LEG KNEE JOINT 3C88-2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-02-15 for C-LEG KNEE JOINT 3C88-2 manufactured by Otto Bock Healthcare Products Gmbh.

Event Text Entries

[38227650] Patient was walking on the street when the c-leg became suddenly free on stance phase (no more breaks) and she fell. No injuries.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9615892-2016-00003
MDR Report Key5436160
Report SourceDISTRIBUTOR
Date Received2016-02-15
Date of Report2016-02-10
Date Mfgr Received2016-01-29
Device Manufacturer Date2014-06-02
Date Added to Maude2016-02-15
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 FDA3
Event Location3
Manufacturer ContactMR. REINHARD WOLKERSTORFER
Manufacturer StreetBREHMSTRASSE 16
Manufacturer CityVIENNA, VIENNA 1110
Manufacturer CountryAU
Manufacturer Postal1110
Manufacturer G1OTTO BOCK HEALTHCARE PRODUCTS GMBH
Manufacturer StreetBREHMSTRASSE 16
Manufacturer CityVIENNA, VIENNA 1110
Manufacturer CountryAU
Manufacturer Postal Code1110
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameC-LEG KNEE JOINT
Generic NameEXTERNAL ABOVE KNEE PROSTHESIS
Product CodeISW
Date Received2016-02-15
Returned To Mfg2015-11-10
Model Number3C88-2
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerOTTO BOCK HEALTHCARE PRODUCTS GMBH
Manufacturer AddressBREHMSTRASSE 16 VIENNA, VIENNA 1110 AU 1110


Patients

Patient NumberTreatmentOutcomeDate
10 2016-02-15

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