BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEN MEDICAL SYSTEMS ALTO SURGICAL TABLE PAD

    MDR report key: 540991 · Received August 27, 2004

    Report

    Report Number
    1221538-2004-00003
    Event Type
    Injury
    Date Received
    August 27, 2004
    Report Date
    July 30, 2004
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT THE PT EXPERIENCED A DEEP TISSUE ULCER FOLLOWING A SIX HOUR PROCEDURE ON THE TABLE PAD. THE INJURIES ARE PURPLISH BLISTERS ON THE PT'S BACK AND BUTTOCKS THAT APPEARED 24-4 HOURS AFTER THE PROCEDURE. COMPLAINANT COULD NOT BE CERTAIN THE INJURIES WERE FROM THE PAD AND DID NOT RETURN THE PAD TO THE MANUFACTURER FOR EVALUATION. A REPRESENTATIVE OF THE MANUFACTURER WHO WAS AT THE FACILITY STATED THAT THE INJURY COULD HAVE RESULTED FROM AN INCORRECT PT TRANSFER TECHNIQUE WHICH CAUSED THE SHEET TO ROLL UP UNDER THE PT. THERE IS NO CONCLUSIVE EVIDENCE THAT THE PAD CAUSED THIS INJURY AND THE FACILITY IS CONTINUING TO USE THE PADS.

    Description of Event or Problem · 2

    DURING A FOLLOW UP CONVERSATION WITH THE COMPLAINANT REPORTED A SECOND INCIDENT IN WHICH A PT EXPERIENCED A DEEP TISSUE UCLER FOLLOWING A SIX HOUR PROCEDURE ON THE TABLE PAD. THE INJURIES ARE PURPLISH BLISTERS ON THE PT'S BACK AND BUTTOCKS THAT APPEARED 24-4 HOURS AFTER THE PROCEDURE. COMPLAINANT COULD NOT BE CERTAIN THE INJURIES WERE FROM THE PAD AND DID NOT RETURN THE PAD TO THE MANUFACTURER FOR EVALUATION. A REPRESENTATIVE OF THE MANUFACTURER WHO WAS AT THE FACILITY STATED THAT THE INJURY COULD HAVE RESULTED FROM AN INCORRECT PT TRANSFER TECHNIQUE WHICH CAUSED THE SHEET TO ROLL UP UNDER THE PT. AGAIN, THERE IS NO CONLCUSIVE EVIDENCE THAT THE PAD CAUSED THIS INJURY AND THE FACILITY IS CONTINUING TO USE THE PADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN MEDICAL SYSTEMS ALTO SURGICAL TABLE PAD SKIN PRESSURE PROTECTOR FMP ALLEN MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention
    2 * Required Intervention