MAUDE Adverse Event Report: ST PAUL LEVEL 1; THERMAL REGULATING SYSTEM

Model Number	SWU-2113
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after use with the product was done, a burn was noticed on the patient.The burn was about 18cm of the armpit.This was found when it was noticed that the product was stuck to the patient in the burned area.The set temperature of the product during use was 40?.And in the last 20 minutes of use, it was set at 44?.The patient was medically treated.

• Brand Name: LEVEL 1
• Common Device Name: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 12522979
• Report Number: 3012307300-2021-09574
• Device Sequence Number: 11869121
• Product Code: DWJ
• UDI-Device Identifier: 10610586043475
• UDI-Public: 10610586043475
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SWU-2113
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1