MAUDE Adverse Event Report: DJO, LLC WRIST BRACE W/BOA, BLK, LT, M; ORTHOSIS, LIMB BRACE

Model Number 221-51-1111

Device Problem No Apparent Adverse Event (3189)

Patient Problems Pain (1994); Rash (2033)

Event Date 12/26/2018

Event Type  malfunction  

Manufacturer Narrative

There is no indication from the reporter that the device will be returned for evaluation.If the device is returned, a follow-up report will be submitted with investigation results.

Event Description

It was reported that the splint caused the patient pain and redness.The patient was placed in the splint in an orthopedic office and complained of the pain and redness, after which she was placed in a new splint.It was discovered that the foam inside of the splint had been cut too short, exposing the hard area on a portion of the splint.

• Brand Name: WRIST BRACE W/BOA, BLK, LT, M
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision st.; vista CA 92081 9663
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, b.c. 22244, ; MX
• Manufacturer Contact: brian becker ; 1430 decision st.; vista, CA 92081-9663 ; 7607343126
• MDR Report Key: 8460755
• MDR Text Key: 140325062
• Report Number: 9616086-2019-00014
• 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: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 221-51-1111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1