MAUDE Adverse Event Report: DJO, LLC AIRCAST CRYOCUFF

Model Number 51A

Device Problems Overheating of Device (1437); Improper or Incorrect Procedure or Method (2017)

Patient Problems Rash (2033); Staphylococcus Aureus (2058); Swelling (2091); Full thickness (Third Degree) Burn (2696)

Event Date 08/05/2013

Event Type  Injury  

Event Description

Complaint received from attorney that alleges a clinician states "individual who overused his thermal device and developed a significant thermal burn to much of the prepatellar region.At the time of his initial office visit, it appeared that the majority of the lateral aspect of his incision and adjacent soft tissue as well as the lateral suprapatellar portal site and the smaller area of proximal medial incision were in serious jeopardy of full thickness damage.The lateral suprapatellar portal site remained dark and appeared that some full thickness necrosis may be present.(b)(4) 2013 follow-up: the infrapatellar incision actually has very healthy granulation tissue, but there are several punctate "pimples" with whiteheads that are (b)(6) lesions.He has full knee range of motion.Lachman to trace with firm end point.There is mild quad atrophy.Calf is soft and nontender.Leg is neurovascularly intact.The lateral infrapatellar lesion skin graft has fully taken." product not received for evaluation or review.No additional information received from patient, lawyer and/or clinician regarding additional details of incident.

• Brand Name: AIRCAST CRYOCUFF
• Type of Device: CRYOCUFF
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A., C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana 2224 4; MX 22244
• Manufacturer Contact: 1430 decision st.; vista, CA 92081 ; 7607271280
• MDR Report Key: 3594872
• MDR Text Key: 4067874
• Report Number: 9616086-2014-00001
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 51A
• 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