MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE PRODUCTS GMBH C-BRACE; KNEE/ANKLE/FOOT ORTHOSIS

Model Number 17B300=R

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Joint Dislocation (2374)

Event Date 01/01/2014

Event Type  Injury  

Event Description

The patient was descending stairs and the knee joint became stiff.He injured his shoulder.

Manufacturer Narrative

Evaluation in progress.

• Brand Name: C-BRACE
• Type of Device: KNEE/ANKLE/FOOT ORTHOSIS
• Manufacturer (Section D): OTTO BOCK HEALTHCARE PRODUCTS GMBH; vienna ; AU
• Manufacturer Contact: reinhard wolkerstorfer ; kaiserstrasse 39; wien 1070 ; AU 1070 ; 3152337866
• MDR Report Key: 4044781
• MDR Text Key: 4909749
• Report Number: 9615892-2014-00010
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• 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: 08/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 17B300=R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2012
• 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; Required Intervention