MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ BAIR HUGGER¿ WARMING UNIT; HYPER/HYPOTHERMA SYSTEM

Model Number	77500
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient specifics are unknown.Model, catalog, lot, and expiration dates: not provided.Contact information is unknown.Device manufacture date is unknown.A sample was not returned.Without a sample, it is not possible to perform any tests to determine if the device met specifications.Without additional information, it is not possible to determine the root cause of the alleged injury or whether the 3m¿ bair hugger¿ warming unit was the root cause.The device labeling shall be reviewed for important contraindications, warnings, and cautions.
Event or Problem Description
A patient allegedly experienced 3rd degree burns to right thigh/leg and permanent damage with the use of the 3m¿ bair hugger¿ warming unit (model not specified).The patient subsequently underwent surgical excisional debridement and split thickness autografting for wound closure on or about (b)(6) 2022.

• Brand Name: 3M¿ BAIR HUGGER¿ WARMING UNIT
• Common Device Name: HYPER/HYPOTHERMA SYSTEM
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144 1000
• Manufacturer (Section G): 3M COMPANY EDEN PRAIRIE; 10351 west 70th street; eden prairie MN 53344
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144-1000 ; 6514612670
• MDR Report Key: 16702435
• Report Number: 2110898-2023-00032
• Device Sequence Number: 5719770
• Product Code: DWJ
• UDI-Device Identifier: 00608223775004
• UDI-Public: 00608223775004
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2023

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
• Operator of Device: Health Professional
• Device Model Number: 77500
• Device Catalogue Number: 77500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Hospitalization; Life Threatening
• Patient Sex: Unknown