BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WARMTOUCH

    MDR report key: 21167284 · Received January 16, 2025

    Report

    Report Number
    2936999-2025-00019
    Event Type
    Injury
    Date Received
    January 16, 2025
    Date of Event
    December 20, 2024
    Report Date
    January 16, 2025
    Manufacturer
    MMJ SA DE CV (USD)
    Product Code
    DWJ
    UDI-DI
    10884521141100
    PMA / PMN Number
    K123083
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: 5030870, WT CAREDRAPE UPPER (LOT# UNKNOWN). MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT USING A THERMAL BLANKET ON THE UPPER LIMBS, IN CONJUNCTION WITH THE WARMTOUCH HEATING EQUIPMENT, SUFFERED A THERMAL BURN ON THE RIGHT ARM. THE SURROUNDING AREA TURNED RED, AND THERE WERE TWO SPOTS, AS IF THE PATIENT'S SKIN WAS LOOSE. A SCALPEL WAS USED, AND THE AREA WAS CLEANED WITH ALCOHOLIC CHLORHEXIDINE. A CONSULTATION WITH A PLASTIC SURGEON DIAGNOSED THE INJURY AS A THERMAL BURN. THE HOSPITALIZATION WAS EXTENDED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251774 WARMTOUCH SYSTEM, THERMAL REGULATING DWJ MMJ SA DE CV (USD) 5016000 10884521141100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE NOTES ON H11.