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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DJO, LLC DONJOY FULL, TROM ADVANCE JOINT, KNEE, EXTERNAL BRACE

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DJO, LLC DONJOY FULL, TROM ADVANCE JOINT, KNEE, EXTERNAL BRACE Back to Search Results
Model Number 11-9115-9
Device Problems Component Incompatible (1108); Patient Device Interaction Problem (4001)
Patient Problem Bone Fracture(s) (1870)
Event Date 09/01/2019
Event Type  Injury  
Manufacturer Narrative

The device has been discarded. As such, no evaluation could be performed. It was reported that the brace was fitted incorrectly which then resulted in the fall. There are no other instances of injuries that were reportedly caused by fit or velcro issues with this product. No further action is warranted.

 
Event Description

It was reported that the velcro strap failure led to brace failure and the patient fell. The patient reportedly sustained an unspecified fracture. Further information was provided that the brace was fitted incorrectly which then resulted in the fall. No further information is currently available.

 
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Brand NameDONJOY FULL, TROM ADVANCE
Type of DeviceJOINT, KNEE, EXTERNAL BRACE
Manufacturer (Section D)
DJO, LLC
1430 decision street
vista CA 96081 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 22244
Manufacturer Contact
brian becker
2900 lake vista drive
lewisville, TX 75067
MDR Report Key9213197
MDR Text Key162985335
Report Number9616086-2019-00073
Device Sequence Number1
Product Code ITQ
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 10/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/21/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number11-9115-9
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2019
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 Unkown

Patient TREATMENT DATA
Date Received: 10/21/2019 Patient Sequence Number: 1
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