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 Problem Injury (2348)

Event Date 01/01/2014

Event Type  Injury  

Event Description

No resistance of joint.Pt fell and injured hand and hip slightly.

Manufacturer Narrative

No further details of injury known.

• Brand Name: C-LEG COMPACT
• Type of Device: NONE
• Manufacturer (Section D): OTTO BOCK HEALTHCARE PRODUCTS GMBH; vienna ; AU
• Manufacturer Contact: reinhard wolkerstorfer ; kaiserstrasse 39; vienna 1070 ; AU 1070 ; 3152337866
• MDR Report Key: 3787177
• MDR Text Key: 4433471
• Report Number: 9615892-2014-00002
• 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
• Type of Report: Initial
• Report Date: 04/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3C96
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization