MAUDE Adverse Event Report: DJO, LLC AIRCAST; AIRSELECT, ELITE, LARGE

Model Number 01EP-L

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/12/2018

Event Type  Injury  

Event Description

Complaint received that alleges "after short time of wearing the walker wounds the patients foot".

Event Description

It was reported that "after short time of wearing the walker wounds the patients foot." the patient was reportedly "in great pain" and "not feeling well".She was reportedly in "so much pain that she cannot sleep properly.The customer was instructed by a doctor to stop using the walker, to elevate her foot, and to take "coamoxicillin 1g tbl.2x/d for 10 days.".

• Brand Name: AIRCAST
• Type of Device: AIRSELECT, ELITE, LARGE
• Manufacturer (Section D): DJO, LLC; 1430 decision st; vista CA 92081 9663
• MDR Report Key: 7714381
• MDR Text Key: 114845693
• Report Number: 9616086-2018-00018
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 01EP-L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other