BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPIC VACPAC

    MDR report key: 562232 · Received December 15, 2004

    Report

    Report Number
    562232
    Event Type
    Malfunction
    Date Received
    December 15, 2004
    Date of Event
    December 1, 2003
    Report Date
    December 15, 2004
    Manufacturer
    OLYMPIC MEDICAL CORP
    Product Code
    BTA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BEANAG SUCTION DEVICE FAILED TO HOLD SUCTION CAUSING THE BEANBAG TO DEFLATE AND BECOME SOFT. FOLLOW-UP PROVIDED BY THE SITE REPORTER IN RESPONSE TO ANALYST QUESTIONS REVEALS THAT THE PATIENT HAD A SHOULDER ARTHROSCOPY, A SMALL BLISTER WAS FOUND ON THE ABDOMEN AND SILVADENE CREAM WAS APPLIED TO THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPIC VACPAC BEANBAG POSITIONING DEVICE BTA OLYMPIC MEDICAL CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR