MAUDE Adverse Event Report: 3M COMPANY 3M BAIR HUGGER 875 WARMING UNIT; SYSTEM, THERMAL REGULATING

Model Number	87500
Health Effect - Clinical Codes	Erythema (1840); Blister (4537); Contact Dermatitis (4546)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The case involves a 52 yof with symptomatic umbilical hernia who presented to ambulatory surgery on (b)(6) 2024 for an elective hernia repair.She underwent an open repair of incisional umbilical hernia.The procedure was without complication and she was transferred to the pacu wherein a gown with built in heating apparatus was applied (3m bair hugger gown product 82003)/inserted into right leg port and was on for 1 hour postoperatively.The patient developed a "rash" on her right upper leg and abdomen that appeared to be raised erythematous patches with multiple blisters extending into the groin.The surgical site and site of the bovie pad were inspected and noted to be clear of any reaction.The heating device was immediately removed and benadryl and ice packs were applied with some improvement.Dermatology was consulted and concurred with diagnosis of contact dermatitis vs superficial burn.A steroid cream/antibiotic was prescribed.3m was notified of the incident.

• Brand Name: 3M BAIR HUGGER 875 WARMING UNIT
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): 3M COMPANY; saint paul MN 55144
• MDR Report Key: 18589846
• Report Number: MW5150788
• Device Sequence Number: 20535810
• Product Code: DWJ
• UDI-Device Identifier: 00707387803438
• UDI-Public: 00707387803438
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/23/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 87500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Race: Black Or African American