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U.S. Department of Health and Human Services

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

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DJO LLC. AIRCAST AIRSELECT, STANDARD, MEDIUM ORTHOSIS, LIMB BRACE Back to Search Results
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.

 
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Brand NameAIRCAST AIRSELECT, STANDARD, MEDIUM
Type of DeviceORTHOSIS, 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 Key10128125
MDR Text Key196913429
Report Number9616086-2020-00020
Device Sequence Number1
Product Code IQI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
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 Received06/08/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number01EF-M
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/24/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 06/08/2020 Patient Sequence Number: 1
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