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

Model Number 310-41-1111

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Burn(s) (1757); Hypersensitivity/Allergic reaction (1907)

Event Date 08/18/2018

Event Type  Injury  

Event Description

It was reported that the patient experienced burns and red patches after 10 days of wearing the device.The splint was removed on the advice of the pharmacy and the patient received care at the hospital with prescription of flammazine and tulle gras.The patient's general practitioner diagnosed an allergic reaction.

Manufacturer Narrative

Further information was provided that the product was given to the patient on (b)(6) 2018 and the skin reaction occurred on (b)(6) 2018 while the patient was gardening, which was four days after starting use as opposed to ten days after as was initially reported.The injury was further described as "oozing red skin".The patient wore the brace tightly and reportedly did not thoroughly dry it after washing.The brace had also gotten wet from perspiration and the patient did not wear a sleeve underneath it.The patient's skin was reportedly normal prior to brace application.The patient was not screened for allergies.The device is reportedly in transit to the manufacturer.

• Brand Name: EXOS
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 7903084
• MDR Text Key: 121558225
• Report Number: 9616086-2018-00022
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 310-41-1111
• Device Lot Number: 022118/180122
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention