MAUDE Adverse Event Report: DJO, LLC AIRCAST; XP DIABETIC WALKER

Model Number 01PD-L

Device Problem No Apparent Adverse Event (3189)

Patient Problem Wound Dehiscence (1154)

Event Date 08/03/2015

Event Type  Injury  

Manufacturer Narrative

Not returned.

Event Description

Complaint received that alleges "he suffered an injury to the bottom of his foot where the impax grid was used to unload an area of discomfort, and after 2 days of wear the area was split open.The patient is diabetic and so he called his hospital to let them know and they were unable to assist him nad just told him to stop wearing the boot.This was approximately 5-6 months ago".Questionnaire was not received from clinician and/or patient.Device not returned to manufacturer for evaluation.

• Brand Name: AIRCAST
• Type of Device: XP DIABETIC WALKER
• 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, mexico 22244 ; MX 22244
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081 ; 7607313126
• MDR Report Key: 5396491
• MDR Text Key: 37014968
• Report Number: 9616086-2016-00003
• Device Sequence Number: 1
• Product Code: IPG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 01PD-L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other