GENIUM - BIONIC PROSTHETIC SYSTEM 3B1=S

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 2014-05-08 for GENIUM - BIONIC PROSTHETIC SYSTEM 3B1=S manufactured by Otto Bock Healthcare Products Gmbh.

Event Text Entries

[4500779] No resistance of joint and patient fell. No injuries.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9615892-2014-00005
MDR Report Key3830099
Report Source08
Date Received2014-05-08
Date of Report2014-05-08
Date of Event2014-01-01
Date Mfgr Received2014-04-09
Device Manufacturer Date2012-03-01
Date Added to Maude2014-06-09
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 CityVIENNA 1070
Manufacturer CountryAU
Manufacturer Postal1070
Manufacturer Phone5233786676
Single Use3
Remedial ActionRP
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGENIUM - BIONIC PROSTHETIC SYSTEM
Generic NameEXTERNAL ABOVE KNEE PROSTHESIS
Product CodeISW
Date Received2014-05-08
Model Number3B1=S
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 2014-05-08

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