BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERMAL PADS

    MDR report key: 888582 · Received August 2, 2007

    Report

    Report Number
    8030647-2007-00091
    Event Type
    Other
    Date Received
    August 2, 2007
    Date of Event
    July 6, 2007
    Report Date
    August 2, 2007
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    DWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION. THE PATIENT HAS AN ALLERGY TO PENICILLIN. WE CANNOT DETERMINE IF THE REACTION WAS TO THE PENICILLIN DERIVATIVE GIVEN PRIOR TO SURGERY OR THE THERMAL PAD USED DURING SURGERY. WITHOUT THE PRODUCT INVOLVED WITH THE INCIDENT TO EVALUATE, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED OF A SKIN INJURY AFTER USE OF THE MEDIUM TORSO PADS FOR THE PATIENT WARMING DEVICE. DURING AN AORTIC VALVE REPLACEMENT SURGERY, THE PATIENT WAS PLACED ON THE WARMING PADS FOR FIVE HOURS AND FIFTEEN MINUTES, WHICH WAS REMOVED AFTER THE SURGERY. FIVE TO SIX BLISTERY HIVES, RANGING FROM 1-4 CM CIRCUMFERENCE WAS NOTED ON THE LEFT SIDE OF THE PATIENT'S BACK, LEVEL WITH LEFT AXILLA, IN THE FATTY FOLD OF CREASE JUST PRIOR TO AXILLA. SEVERAL TINY BLISTERS HAD BEEN NOTED ON THE RIGHT SIDE, BUT ALL HAD "POPPED" OR BURST, AND ONLY A SMALL AREA OF REDNESS REMAINS. THE PATIENT WAS RECOMMENDED TO SEE THE FACILITY WOUND CARE NURSE TO ASSESS TREATMENT. KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED ABOVE BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMAL PADS PATIENT WARMING DWJ AVENT S. DE R.L. DE C.V. NA 387200

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR