MAUDE Adverse Event Report: DONJOY (DJ ORTHOPEDIC) ICEMAN CLEAR3+; PACK, HOT OR COLD, WATER CIRCULATING

Catalog Number 11-0679-9

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Burn(s) (1757); Necrosis (1971); Necrosis Of Flap Tissue (1972); Pain (1994); Full thickness (Third Degree) Burn (2696)

Event Date 11/05/2015

Event Type  malfunction  

Event Description

The patient underwent a right total knee last fall.She had received a peri-capsular injection for pain control which contained 2 cc of 0.5% marcaine/ hr (for 36 hrs).The patient was sent home with a cold therapy product (donjoy iceman clear3+cold therapy unit).On her first post-op visit, she was found to be experiencing a fair amount of pain and had been taking pain medication and icing regularly.She reportedly had not been using a barrier between her skin and the ice, and the provider described an ice burn on the medial and lateral aspects of her incision.She was instructed to stop using ice therapy.The patient was seen again approximately two and a half weeks later and found to have multiple blisters on her knee and areas of necrosis.Xeroform was applied, keflex was ordered and dressing and knee immobilizer were placed.Approximately two weeks later, there was no significant drainage of necrotic wound.The patient was referred to a plastic surgeon and has undergone a series of staged reconstructive procedures including grafts and muscle flap closure.Grafting required removal of the implant and placement of an antibiotic spacer approximately six weeks post right total knee surgery.

• Brand Name: ICEMAN CLEAR3+
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): DONJOY (DJ ORTHOPEDIC); 1430 decision street; vista CA 92081
• MDR Report Key: 5540734
• MDR Text Key: 41632912
• Report Number: 5540734
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 11-0679-9
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/13/2016
• Event Location: Home
• Date Report to Manufacturer: 01/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 0
• Treatment: OTHER, PATIENT WAS APPLYING DIRECT ICE TO THE AR
• Patient Age: 67 YR