MAUDE Adverse Event Report: DJO, LLC EXOS; SHRT ARM FRACTURE BRACE, BLK, LT, L

Model Number 310-61-1111

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 02/10/2017

Event Type  Injury  

Manufacturer Narrative

Device not returned.

Event Description

Service of summons was manufacturers first notification of this event.Plaintiffs counsel claims in the complaint that "skin reacted to the material of the brace and he developed first and second degree burns and boils on his forearm".Questionnaire not received from clinician and/or patient.Device not returned to manufacturer for evaluation.

• Brand Name: EXOS
• Type of Device: SHRT ARM FRACTURE BRACE, BLK, LT, L
• Manufacturer (Section D): DJO, LLC; 1430 decision street; 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, mexico 22244 ; MX 22244
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081 ; 7607313126
• MDR Report Key: 6361281
• MDR Text Key: 68416483
• Report Number: 9616086-2017-00005
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 310-61-1111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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
• Patient Outcome(s): Other