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

Model Number B-24290000X

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Swelling (2091); Ulcer (2274)

Event Date 07/15/2014

Event Type  Injury  

Event Description

Pt did not tell fitter of the diabetic medical condition.Orthotic fitter placed standard rebound air walker on the pt.Pt returned 23 weeks later with a quarter size ulcer on the plantar surface of the mla.Waffle pattern of the eva caused blistering due to diabetic medical condition.Fitter replaced the product with a donjoy aircast.Ossur sales rep then fit the pt with the diabetic walker boot.

Manufacturer Narrative

Pt did not inform the orthotic fitter the he was diabetic.Fitter provided a regular walker for the pt.When the pt informed the fitter of his diabetes, the fitter proved the pt with a diabetic model walker.

• Brand Name: REBOUND AIR WALKER LOW TOP
• Type of Device: JOINT, ANKLE, EXTERNAL BRACE
• Manufacturer (Section D): OSSUR; foothill ranc CA
• Manufacturer Contact: karen montes ; 27051 towne centre; foothill ranch, CA 92610 ; 9493823741
• MDR Report Key: 4054094
• MDR Text Key: 4908385
• Report Number: 2085446-2014-00003
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2014

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-24290000X
• Device Catalogue Number: B-24290000X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2014
• Initial Date FDA Received: 08/27/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other