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".

• Brand Name: AIRCAST
• Type of Device: AIRSELECT, ELITE, LARGE
• Manufacturer (Section D): DJO, LLC; 1460 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, mx
• Manufacturer Contact: william fisher ; 1460 decision street; vista, CA 92081-9663
• MDR Report Key: 7715757
• MDR Text Key: 114884876
• Report Number: 9616086-2018-00019
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/24/2018

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: Lay User/Patient
• Device Model Number: 01EP-L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other