MAUDE Adverse Event Report: DJO LLC EXOS SAFB-OT BRACE; ORTHOSIS, LIMB BRACE

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Bruise/Contusion (1754); Nerve Damage (1979)

Event Date 02/01/2021

Event Type  Injury  

Event Description

Djo exos safb-ot brace tightened by itself over several days causing bruising and ulnar nerve damage.Fda safety report id # (b)(4).

• Brand Name: EXOS SAFB-OT BRACE
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): DJO LLC
• MDR Report Key: 11783217
• MDR Text Key: 249517188
• Report Number: MW5101204
• Device Sequence Number: 1
• Product Code: IQI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 50