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

Model Number SWU-2113

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 08/24/2021

Event Type  Injury  

Event 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
• Type of Device: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; 2-12-12, kitanagase-omotemachi; minneapolis, MN 55442
• MDR Report Key: 12522979
• MDR Text Key: 273071624
• Report Number: 3012307300-2021-09574
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 10610586043475
• UDI-Public: 10610586043475
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SWU-2113
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2021
• 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: N
• Patient Sequence Number: 1