MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC KOOL KIT

Model Number	900
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint #(b)(4) received.There were no allegations of device malfunction.The product is not expected to return to gentherm for evaluation.
Event or Problem Description
The customer reports they have had some issues recently where two different patients developed some pressure injuries (blister) to their shoulder blade and both were wearing the patient vests from the kool kits.Second event.

• Brand Name: KOOL KIT
• Common Device Name: KOOL KIT
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller rd; cincinnati OH 45241
• Manufacturer (Section G): GENTHERM MEDICAL, LLC; 12011 mosteller rd; cincinnati OH 45241
• Manufacturer Contact: angie gegner ; 12011 mosteller rd; cincinnati, OH 45241 ; 5133265228
• MDR Report Key: 22963231
• Report Number: 1516825-2025-00019
• Device Sequence Number: 21241691
• Product Code: DWJ
• UDI-Device Identifier: 10613031829006
• UDI-Public: 10613031829006
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 900
• Device Catalogue Number: 82900
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown