MAUDE Adverse Event Report: DJO, LLC AIRCAST; AIRSELECT, SHORT, MEDIUM

Model Number 01ES-M

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Swelling (2091)

Event Date 02/27/2018

Event Type  Injury  

Event Description

Complaint received that alleges patient had an allergic reaction to the foot : elephant foot syndrome, large swelling, deformed foot, pustules.Symptoms noticed after three days wearing device.Treatment with antibiotics / corticosteroids that immediately stopped the allergic reaction.

Manufacturer Narrative

Product was used, air select is fine it is good inside and on the outside, the functionality of the bladders is correct, no damaged components, unable to determine the cause of the issue.

• Brand Name: AIRCAST
• Type of Device: AIRSELECT, SHORT, MEDIUM
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 7325031
• MDR Text Key: 101949363
• Report Number: 9616086-2018-00004
• Device Sequence Number: 1
• Product Code: ITW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 01ES-M
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other