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

Model Number	77500
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Burn(s) (1757); Erythema (1840); Pain (1994); Scar Tissue (2060); Blister (4537)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1-a2: not provided.D4: catalog, serial, lot#: not provided & expiration date: not applicable.E1: reporter address: not provided.H4: manufacture date: not applicable.H10: a product sample was not returned to 3m for analysis.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 female allegedly underwent surgery on (b)(6)2023 at the (b)(6) center and experienced an injury noted as a left wrist 1st degree burn, blister, redness with severe pain that reportedly healed after approximately one month with the use of the 3m¿ bair hugger¿ warming unit.In pre-op, the nurse placed the 3m¿ bair hugger¿ warming unit on the left side of the bed.Postoperative, the patient felt a burning sensation at her left arm which she showed to the nurse who reportedly stated, "might have just lean over her arm during the surgery" and applied a cold pack on the patient's left arm.The patient went home, removed the cold pack, and observed blisters.The patient noted she thought the cold pack caused more blistering which reportedly did not look good, and presented to urgent care.The physician diagnosed the injury as a burn and prescribed a burning cream that reportedly did not help.The patient's current status noted the burn is dry, and the patient is applying scar cream to lighten up the dark scar.

• 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: 16887077
• Report Number: 2110898-2023-00039
• Device Sequence Number: 6326750
• Product Code: DWJ
• UDI-Device Identifier: 00608223775004
• UDI-Public: 00608223775004
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2023

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: 04/10/2023
• Initial Report FDA Received Date: 05/08/2023
• 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
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian