MAUDE Adverse Event Report: DJO, LLC DONJOY; OA ADJUSTER 3, MEDIAL, LT, L

Model Number 11-1591-4

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

Patient Problem Injury (2348)

Event Date 04/30/2018

Event Type  Injury  

Event Description

Per 21cfr part 803, an mdr reportable event.Complaint received that alleges "was given bilateral oa adjuster 3 braces from the va and when he walks the braces sometimes hit each other at the hinge.While on a cruise, the braces hit each other in a tight space and he fell because of the hinges getting tangled up into each other.He fell into the side of the ship and injured his shoulder, knee and ribs.Went to a physician afterwards".Questionnaire not received from customer or clinician.Device not received manufacturer at this time.

• Brand Name: DONJOY
• Type of Device: OA ADJUSTER 3, MEDIAL, LT, L
• 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, 22244 ; MX 22244
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081-9663 ; 7607343126
• MDR Report Key: 7491057
• MDR Text Key: 107490849
• Report Number: 9616086-2018-00012
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/07/2018

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: No Information
• Device Model Number: 11-1591-4
• 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: 05/07/2018
• 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