BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAYMAR INDUSTRIES, INC.

    MDR report key: 201253 · Received December 9, 1998

    Report

    Report Number
    MW1015168
    Event Type
    Injury
    Date Received
    December 9, 1998
    Date of Event
    October 19, 1998
    Report Date
    December 3, 1998
    Manufacturer
    GAYMAR INDUSTRIES, INC.
    Product Code
    ILO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAS A HISTORY OF A HERNIATED LUMBAR DISC. ON THE ADMISSION DATE PT HAD LOWER BACK PAIN RADIATING TO LOWER LEGS. PT WAS LYING ON A K-PAD, PT STATED THAT THE K-PAD BURNED HER. NOTED SEVERAL REDDENED AREAS. NO BLISTER OR DRAINAGE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAYMAR INDUSTRIES, INC. K PAD ILO GAYMAR INDUSTRIES, INC. K 20 *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention