MAUDE Adverse Event Report: OSSUR REHAB CONTOUN AIR LIGHT R

Model Number B-220500000

Device Problems Mechanical Problem (1384); Device Slipped (1584)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 09/04/2012

Event Type  Injury  

Event Description

The pt was wearing the rehab knee brace while walking up a flight of stairs.The pt claims the velcro on the brace failed causing him to fall.He was able to catch and brace himself but he landed on his knee and fractured his patella.He went in for surgery the next day.

• Brand Name: REHAB CONTOUN AIR LIGHT R
• Manufacturer (Section D): OSSUR; reykjavik ; IC
• Manufacturer Contact: karen montes ; 27051 towne centre; foothill ranch, CA 92610 ; 9493823741
• MDR Report Key: 4658405
• MDR Text Key: 5683545
• Report Number: 3003764610-2015-00008
• Device Sequence Number: 1
• Product Code: ISS
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: B-220500000
• Device Catalogue Number: B-220500000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/18/2012
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention