MAUDE Adverse Event Report: DJO, LLC EXOS; SHORT ARM FRACTURE BRACE

Model Number 310-31-2388

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

Patient Problem Suture Abrasion (2497)

Event Date 06/29/2016

Event Type  Injury  

Manufacturer Narrative

Not returned.

Event Description

Complaint received that alleges "patient requiring stitches to suture and open wound allegedly caused by brace".Questionnaire not received from clinician and/or patient.Device not returned to manufacturer for evaluation.

• Brand Name: EXOS
• Type of Device: SHORT ARM FRACTURE BRACE
• 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: 5779450
• MDR Text Key: 49077670
• Report Number: 9616086-2016-00016
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 310-31-2388
• Was Device Available for Evaluation?: 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): Required Intervention