MAUDE Adverse Event Report: DJO LLC. AIRCAST AIRSELECT, STANDARD, MEDIUM; ORTHOSIS, LIMB BRACE

Model Number 01EF-M

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Irritation (1941); Patient Problem/Medical Problem (2688)

Event Date 04/24/2020

Event Type  malfunction  

Manufacturer Narrative

No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.

Event Description

It was reported that the patient "had silver fibers embedded in her leg and had shiny skin for weeks" after wearing an aircast airselect standard brace.The patient also reported that she now has issues with her left shin that she did not have otherwise.There has been no reported patient injury or harm at this time.The device has not been returned to the manufacturer for evaluation.If the device is returned, a follow-up report will be submitted upon completion of device evaluation.

• Brand Name: AIRCAST AIRSELECT, STANDARD, MEDIUM
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): DJO LLC.; 1430 decision street; vista, ca
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S. A. DE C. V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, b.c., mx 22244 ; MX 22244
• Manufacturer Contact: christine bonczyk ; 2900 lake vista drive; lewisville, ca
• MDR Report Key: 10128125
• MDR Text Key: 196913429
• Report Number: 9616086-2020-00020
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 01EF-M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other