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

Model Number 77500

Device Problem Human-Device Interface Problem (2949)

Patient Problem Burn(s) (1757)

Event Date 06/01/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 312898625
• Report Number: 2110898-2023-00032
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00608223775004
• UDI-Public: 00608223775004
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 77500
• Device Catalogue Number: 77500
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 04/07/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Hospitalization; Life Threatening