MAUDE Adverse Event Report: OSSUR AMERICAS REBOUND AIR WALKER; JOINT, ANKLE, EXTERNAL BRACE

Model Number B-242900003

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Date 08/18/2015

Event Type  Injury  

Event Description

Patient using a rebound air walker walking boot claims the strap broke causing a fall.The pharmacy stated the patient claims they required a hospital visit, but is unable to verify.

• Brand Name: REBOUND AIR WALKER
• Type of Device: JOINT, ANKLE, EXTERNAL BRACE
• Manufacturer (Section D): OSSUR AMERICAS; 27051 towne centre; foothill ranch CA 92610
• Manufacturer (Section G): OSSUR AMERICAS; 27051 towne centre; foothill ranch CA 92610
• Manufacturer Contact: karen montes ; 27051 towne centre drive; foothill ranch, CA 92610 ; 9493823741
• MDR Report Key: 5243254
• MDR Text Key: 31914162
• Report Number: 2085446-2015-00002
• Device Sequence Number: 1
• Product Code: ITW
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: B-242900003
• Device Catalogue Number: B-242900003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2015
• Initial Date FDA Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other