BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M¿ BAIR HUGGER® PATIENT WARMING UNIT

    MDR report key: 18266295 · Received December 5, 2023

    Report

    Report Number
    2110898-2023-00098
    Event Type
    Injury
    Date Received
    December 5, 2023
    Date of Event
    September 11, 2023
    Report Date
    August 7, 2024
    Manufacturer
    3M COMPANY
    Product Code
    DWJ
    PMA / PMN Number
    K060865
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO CORRECT THE FOLLOWING SECTIONS: D1 BRAND NAME: 3M¿ BAIR HUGGER¿ WARMING UNIT TO 3M¿ BAIR HUGGER® PATIENT WARMING UNIT D3 MANUFACTURER NAME, CITY AND STATE: 3M HEALTH CARE TO 3M COMPANY D4 MODEL #: 775 TO 77500 D4 CATALOG #: BLANK TO 77500 D4 UNIQUE IDENTIFIER (UDI) #: (B)(4) TO NI.

    Additional Manufacturer Narrative · 0

    E2-E3: IT IS UNKNOWN IF THE REPORTER IS A HEALTH PROFESSIONAL. D4: SERIAL NUMBER: NOT AVAILABLE. H4: MANUFACTURE DATE: NOT AVAILABLE. H10: 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 DEFINITIVELY DETERMINE THE ROOT CAUSE. THE DEVICE LABELING SHALL BE REVIEWED FOR IMPORTANT CONTRAINDICATIONS, WARNINGS, AND CAUTIONS.

    Description of Event or Problem · 0

    A HOSPITAL REPORTED A CHILD UNDERWENT A COARCTATION AORTA DILATATION BY BALLOON KIT WITH STENT PLACEMENT, AND SUBSEQUENTLY EXPERIENCED A COMPLETE LEFT BUTTOCK 2ND DEGREE BURN THAT EXTENDED TO THE BOTTOM OF THE RIGHT RIBS DURING USE OF THE 3M¿ BAIR HUGGER¿ WARMING UNIT, MODEL 775.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049133 3M¿ BAIR HUGGER® PATIENT WARMING UNIT HYPER/HYPOTHERMIA SYSTEM DWJ 3M COMPANY 77500

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Unknown Other