MAUDE Adverse Event Report: DJO, LLC DONJOY; REACTION KNEE BRACE M/L, GRAY

Model Number 11-0215-3

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

Patient Problem Joint Disorder (2373)

Event Date 03/08/2016

Event Type  Injury  

Manufacturer Narrative

Event Description

Complaint received that alleges "patella luxation (2.Time) after using the product 14 days, thick knee, pain, medical treatment necessary".Questionnaire was received from clinician and/or patient.Questionnaire indicated that the patient was prescribed the device for a prior patella luxation.While wearing the brace a second patella luxation occurred while opening a window.Additional treatment was required for the second patella luxation.Device not returned to manufacturer for evaluation.No indication event caused or contributed to permanent impairment or death.

• Brand Name: DONJOY
• Type of Device: REACTION KNEE BRACE M/L, GRAY
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081 ; 7607313126
• MDR Report Key: 5514438
• MDR Text Key: 40804122
• Report Number: 2020737-2016-00002
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 11-0215-3
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/10/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other