MAUDE Adverse Event Report: DJO, LLC DONJOY; DRYTEX, LAT PAT KNEE, RT, M, BLK

Model Number 11-0659-3-06060

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

Patient Problems Anaphylactic Shock (1703); Unspecified Infection (1930)

Event Date 05/13/2015

Event Type  Injury  

Event Description

Complaint received from customer that alleges "anaphylactic shock and infected sores following wearing the lateral j brace.I have two of the.I was seen for treatment and given cipro capsules, rocephin 1000mg injection, and bactroban ointment".Questionaire was not received from clinician and/or pt.Device not returned to mfr for eval.

• Brand Name: DONJOY
• Type of Device: DRYTEX, LAT PAT KNEE, RT, M, BLK
• Manufacturer (Section D): DJO, LLC; 1430 decision st.; vista, CA 92081
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; 20230 submetropoli el florido; carretera libre tijuana tecate; tijuana 2224 4; MX 22244
• Manufacturer Contact: 1430 decision st.; vista, CA 92081 ; 7607271280
• MDR Report Key: 4858602
• MDR Text Key: 5875648
• Report Number: 9616086-2015-00014
• Device Sequence Number: 1
• Product Code: LSB
• 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: Other
• Type of Report: Initial
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 11-0659-3-06060
• Was Device Available for Evaluation?: No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other