MAUDE Adverse Event Report: DJO, LLC DONJOY X-ACT ROM ELBOW BRACE; SUPPORT, ARM

Model Number 11-9121

Device Problem Product Quality Problem (1506)

Patient Problems Abrasion (1689); Bruise/Contusion (1754)

Event Date 04/30/2021

Event Type  Injury  

Event Description

Migration, comfort and skin damage problems w/ x-act rom elbow brace: on april 14 i had bilateral tricep rupture repair.On april 27 my splint was removed and my ortho had the donjoy rep "fit" both arms with the donjoy x-act rom elbow braces.The rep did a poor job and my son and i had to make several adjustments to get them to fit properly.Even when the straps are cinched so tight that they make deep indentations into my arms, both braces slip down over my wrists within an hour or two of placement.Of course then the pivot point of the brace is at least one inch below my elbow.So with my wrist rom limited by the brace strap over them and the pivot point migrated, my 20 deg rom is reduced to 10 deg.In addition, donjoy's "unique anti-migration material", aka extremely aggressive adhesive discs, removed the first layer of skin off a one inch diameter area of both my forearms, and i have various other open sores from abrasion and migration.See photos below of the wounds and the poor fit.The donjoy braces were simply not working for me, didn't fit properly and caused severe contusion on my forearms.I then purchased a pair of competitive braces from egoactive.These braces fit great, are comfortable, don't migrate and are not causing any injury to my skin.At first the donjoy customer care team engaged with me, but they were apparently solely interested in retrieving the braces from me.Now donjoy will not return my calls or emails.I've asked them to reverse their request for reimbursement with my medical insurance carrier so that i submit my out-of-pocket purchase of the ergoactive braces to me carrier.So far they have not.Insurance fraud? fda safety report id # (b)(4).

• Brand Name: DONJOY X-ACT ROM ELBOW BRACE
• Type of Device: SUPPORT, ARM
• Manufacturer (Section D): DJO, LLC
• MDR Report Key: 11975777
• MDR Text Key: 255766111
• Report Number: MW5101807
• Device Sequence Number: 1
• Product Code: IOY
• 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: 06/08/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 11-9121
• 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: 63 YR
• Patient Weight: 79