MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE PRODUCTS GMBH C-LEG COMPACT; NONE

Model Number 3C96

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

No resistance of joint.Patient fell.No injuries.

• Brand Name: C-LEG COMPACT
• Type of Device: NONE
• Manufacturer (Section D): OTTO BOCK HEALTHCARE PRODUCTS GMBH; vienna ; AU
• Manufacturer Contact: kaiserstrasse 39; di reinhard woklerstorfer; vienna 1070 ; 3152337866
• MDR Report Key: 3906865
• MDR Text Key: 20329732
• Report Number: 9615892-2014-00001
• Device Sequence Number: 1
• Product Code: ISW
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3C96
• Initial Date Manufacturer Received: 02/21/2014
• Initial Date FDA Received: 03/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2007
• Patient Sequence Number: 1