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U.S. Department of Health and Human Services

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

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DJO, LLC EXOS SHORT ARM FRACTURE BRACE Back to Search Results
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.

 
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Brand NameEXOS
Type of DeviceSHORT 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 Key5779450
MDR Text Key49077670
Report Number9616086-2016-00016
Device Sequence Number1
Product Code IQI
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
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 Received07/08/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number310-31-2388
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
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 Unkown

Patient TREATMENT DATA
Date Received: 07/08/2016 Patient Sequence Number: 1
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