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

Model Number 01ES-M

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Traumatic Wound Infection (2447)

Event Date 12/01/2017

Event Type  Injury  

Event Description

Complaint received that alleges "walking boot deflated and without warning or notice the position of my foot changed in the boot and caused a huge blister on the outside of the foot.It was at the 3 week mark or so that the new boot did the same thing on the right side and deflated again and shifted my foot back to the side of the boot and rubbed another blister.I am not a diabetic but i do have neuropothy in my feet and couldn't feel the injury or the rubbing as it happened.To my surprise at bed time when i took off the boot i discovered the injury.It was this second time that the blister was bigger.As the blister healed i protected it in the boot with padding so it wouldn't rub on the right side of the boot.It was about 7 weeks after getting this second blister that the injury occured.The blister was just all about closed up and nothing there when all of a sudden it got infected.It started out in the am as being "wet" and i didn't understand and put a bandaid on it.That evening when i took off my boot the blister was the size of a quarter and over night it grew to the size of a fifty cent piece.I had the wound lanced right away and ended up in er when the area took off and spread on my foot.It took 6-7 weeks of having the wound packed and certain medicines put on the wound to help it heal.I was seen at a limb preservation office by a dr (b)(6)".Questionnaire not received from customer or clinician.Device not received manufacturer at this time.

Manufacturer Narrative

The unit was evaluated; the product was used (it looks worn out), the right aircell is leaking because of a hole found on the aircell , broken front panel & liner ripped by the side of out in the back) it is not possible to confirm the complaint because the product doesn't have any foreign abrasive material that may propitiate this condition.Patient confirmed in questionnaire provided, being afflicted with charcot disease (nueroarthapy).Each device is provided with an ifu indicating the following: "do not use this device if you cannot feel sensations whether due to post-op anethesia, nerve, skin or other conditions".

• Brand Name: AIRCAST
• Type of Device: AIRSELECT, SHORT, MEDIUM
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, 22244 ; MX 22244
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081-9663 ; 7607343126
• MDR Report Key: 7113116
• MDR Text Key: 94699556
• Report Number: 9616086-2017-00023
• Device Sequence Number: 1
• Product Code: KNP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Yes
• 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