BEUDAMED
    FDA Adverse Event Other Summary report: N

    GAYMAR

    MDR report key: 274202 · Received April 18, 2000

    Report

    Report Number
    MW1018688
    Event Type
    Other
    Date Received
    April 18, 2000
    Date of Event
    March 29, 2000
    Report Date
    April 11, 2000
    Manufacturer
    GAYMAR INDUSTRIES, INC.
    Product Code
    DWJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IN HOSP FOR PERIPHERAL VASCULAR DISEASE. PT HAD RIGHT PROFUNDA ARTERIOPLASTY, RIGHT PFA TO PERONEAL FEMORAL REVERSE SAPHENOUS VEIN GRAFT. AFTER PROCEDURE, PT NOTED TO HAVE HAND-SIZED SKIN LESION ON RIGHT BUTTOCK. UNKNOWN IF PRESSURE SORE, BOVIE BURN OR BURN FROM HYPOTHERMIA BLANKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAYMAR HYPOTHERM BLANKET DWJ GAYMAR INDUSTRIES, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other