MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO MEDI-THERM; THERMAL REGULATING SYSTEM

Catalog Number MTA7900

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 10/01/2020

Event Type  malfunction  

Event Description

It was reported that while in use on high temperature mode, the unit overheated, causing the patient to be burned.No information has been provided regarding the severity or treatment of the injury.Attempts have been made to reach the customer for more information, however they have not responded to these attempts.

Manufacturer Narrative

Investigation is complete.B5 and h codes updated to match investigation results.

Event Description

It was reported that while in use on high temperature mode, the unit overheated, causing the patient to be burned.The patient injury was treated with xeroform.It was further reported that the patient had fragile skin and multiple co-morbidities that may have contributed to the alleged burn.

• Brand Name: MEDI-THERM
• Type of Device: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 10749565
• MDR Text Key: 213495135
• Report Number: 0001831750-2020-01190
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• PMA/PMN Number: K152266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MTA7900
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other