MAUDE Adverse Event Report: DJO, LLC DJO DEFIANCE

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Phlebitis (2004); Thrombosis (2100)

Event Date 08/31/2013

Event Type  Injury  

Event Description

Complaint received that alleges "strong pain in the right leg, the brace caused two blood clots (superficial), resulting in a phlebitis." product not received for evaluation or review.Additional information received from patient include the following treatment data, "customer was placed in bed rest for a week and took arixtra 2.5 mg, then the dosis was increased to 5 mg for 6 weeks and is back to one injection a day of arixtra 2.5 mg, still using the injection one a day.".

• Brand Name: DJO DEFIANCE
• Type of Device: DEFIANCE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081
• Manufacturer (Section G): DJO, LLC; 3151 scott street; vista CA 92081
• Manufacturer Contact: 1430 decision street; vista, CA 92081 ; 7607271280
• MDR Report Key: 3634609
• MDR Text Key: 3983667
• Report Number: 2020737-2014-00001
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2014
• 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): Required Intervention