MAUDE Adverse Event Report: DJO, LLC DONJOY; DEFIANCE FP

Model Number CONV DEFIANCE FP

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 03/23/2017

Event Type  Injury  

Event Description

Complaint recieved that alleges "(b)(6) was running and his brace hit is other leg re-tearing his acl".

• Brand Name: DONJOY
• Type of Device: DEFIANCE FP
• Manufacturer (Section D): DJO, LLC; 1460 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJO, LLC; 3151 scott street; vista CA 92081 9663
• Manufacturer Contact: william fisher ; 1460 decision street; vista, CA 92081-9663
• MDR Report Key: 7569727
• MDR Text Key: 110093054
• Report Number: 3012446970-2018-00004
• 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
• Report Date: 06/05/2018

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 DEFIANCE FP
• 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: 06/05/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other