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

Model Number 01EP-L

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

Patient Problem Thrombosis (2100)

Event Date 05/02/2018

Event Type  Injury  

Event Description

Complaint received that alleges "customer developed dvt whilst wearing, boot was being worn in conjunction with procare heel wedges".Questionnaire not received from customer or clinician.Device not received manufacturer at this time.

Manufacturer Narrative

Product is in very good condition, with minimal use and is working as designed.There is nothing obvious which could be to blame with this walker.It also appears that the hospital had to select a size large walker i assume due to her calf size as if they went on her foot size alone they would have selected a size small walker ((b)(6) shoe size 4).This could have contributed to the foot moving around inside the boot.

• Brand Name: AIRCAST
• Type of Device: AIRSELECT, ELITE, LARGE
• Manufacturer (Section D): DJO, LLC; 1460 decision street; vista CA 92081 9663
• MDR Report Key: 7499099
• MDR Text Key: 107746810
• Report Number: 9616086-2018-00013
• 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: consumer,foreign
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 01EP-L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACHILLES WEDGE , 79-95130; ACHILLES WEDGE , 79-95130
• Patient Outcome(s): Other