MAUDE Adverse Event Report: DJO, LLC DONJOY; ADJUSTABLE OA DEFIANCE

Model Number CONV ADJ OA DEFIANCE

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

Patient Problem Thrombosis (2100)

Event Date 04/09/2018

Event Type  Injury  

Event Description

Complaint received that alleges "brace cause a blood clot in his lower leg".Questionnaire not received from customer or clinician.Device not received manufacturer at this time.

Manufacturer Narrative

Per the condition, functionality, and manufacturing form; the brace is built within specifications.No issues were found.

• Brand Name: DONJOY
• Type of Device: ADJUSTABLE OA DEFIANCE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 7468518
• MDR Text Key: 106739871
• Report Number: 3012446970-2018-00002
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/17/2018

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: CONV ADJ OA DEFIANCE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2018
• Supplement Dates Manufacturer Received: 10/11/2018
• Supplement Dates FDA Received: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other