MAUDE Adverse Event Report: THERMOTEK, INC. THERMO TEK; PACK, HOT OR COLD, WATER CIRCULATING

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

Patient Problems Ecchymosis (1818); Swelling (2091); Full thickness (Third Degree) Burn (2696)

Event Date 12/01/2015

Event Type  malfunction  

Event Description

The patient presented early (b)(6) for her post-op appt from her right knee surgery.Her doctor noticed she had burns on her knee that came from the cold pack machine she was given.This was the first time he was made aware for the first time of any issue with her wound/healing.Eschar development over medial side of her right knee incision, mid incision was noted 6cm x 3cm.Ecchymosis over the knee joint was noted with moderate swelling, with no active drainage and no sign of infection.(b)(6) states by email approximately two weeks later that manufacturer (thermotek.Inc) has deemed that the machine functions normally.A written report was to follow.The patient underwent ops at the same time for wound debridement after 4 days on wound vac, and is being managed in wound clinic four days later.Per the dr., she may require skin graft if doesn't close on its own, but overall her outlook is favorable.In retrospect, he believes the patient may not have been burned, although he can't be sure.

• Brand Name: THERMO TEK
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): THERMOTEK, INC.; 1200 lakeside parkway ste 200; flower mound TX 75028
• MDR Report Key: 5494778
• MDR Text Key: 40176915
• Report Number: 5494778
• 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: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2016
• 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
• Patient Age: 58 YR