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

Model Number 11-1593-4

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Tissue Damage (2104)

Event Date 07/02/2018

Event Type  Injury  

Event Description

Complaint received that alleges "i have deep cuts in the top of the thigh.The bottom of the brace digs into my calf muscle causing blisters and bruising having only worn them for a few hours".

• Brand Name: DONJOY
• Type of Device: ADJUSTER 3, LATERAL, LT, L
• 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
• Manufacturer Contact: william fisher ; 1460 decision street; vista, CA 92081-9663
• MDR Report Key: 7689998
• MDR Text Key: 114043865
• Report Number: 9616086-2018-00016
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 11-1593-4
• 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