BEUDAMED
    FDA Adverse Event Summary report: N

    T PUMP

    MDR report key: 1052603 · Received May 20, 2008

    Report

    Report Number
    1052603
    Date Received
    May 20, 2008
    Date of Event
    May 4, 2008
    Report Date
    May 20, 2008
    Manufacturer
    GAYMAR INDUSTRIES, INC.
    Product Code
    ILO
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT ADMITTED FOR REDO REPAIR OF HIS PARAESOPHAGEAL HERNIA, AND NISSEN FUNDOPLICATION. HE WAS TAKEN TO SURGERY AND GIVEN GENERAL ANESTHESIA WITH AN EPIDURAL FOR POST-OPERATIVE PAIN MANAGEMENT. POST-OPERATIVELY HE COMPLAINED OF NECK PAIN. A HEATING PAD AND PT WERE ORDERED BY THE PHYSICIAN. HE WAS GIVEN A PAD FOR HEAT THE DAY AFTER SURGERY. TWO DAYS LATER IT WAS NOTED HIS BACK WAS RED WITH BLISTERS. THE REDDENED AREAS AND BLISTERS WERE IN THE SHAPE OF THE PATTERN ON THE PAD. THE PATIENT STATES HE SLEPT ON THE PAD BUT COULD NOT FEEL IT BURNING BECAUSE OF THE EPIDURAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T PUMP HEAT THERAPY UNIT ILO GAYMAR INDUSTRIES, INC. TP 200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR OTHER| OTHER