MAUDE Adverse Event Report: DJO, LLC DONJOY; SE 4PT.,CI,RT,L,BLK/GREY

Model Number 11-0984-4-06160

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 02/18/2018

Event Type  Injury  

Event Description

Complaint received that alleges "injury reported incident, in a game using the brace, the inside side of the brace broke and severely sprained his mcl".Questionnaire not received from customer or clinician.Device not received manufacturer at this time.

Manufacturer Narrative

The unit was evaluated; the item was used, the brace is fine only a little dirty and the screws of the hinge on the left side were removed, no component is damaged, it is not possible to determine the cause of the problem.

• Brand Name: DONJOY
• Type of Device: SE 4PT.,CI,RT,L,BLK/GREY
• Manufacturer (Section D): DJO, LLC; 1460 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, mx 22244 ; MX 22244
• Manufacturer Contact: william fisher ; 1460 decision street; vista, CA 92081-9663 ; 7607343126
• MDR Report Key: 7303244
• MDR Text Key: 101170465
• Report Number: 9616086-2018-00002
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 11-0984-4-06160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2018
• Supplement Dates Manufacturer Received: 05/15/2018
• Supplement Dates FDA Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other