BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBB

    MDR report key: 3131169 · Received May 22, 2013

    Report

    Report Number
    MW5030288
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    GLENVEIGH MEDICAL
    Product Code
    OQY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PROBLEM #1: PRODUCT HAS SEVERAL LABELS PLACED ON TOP OF EACH OTHER. WHEN THE LABELS ARE PEELED BACK, EACH LAYER OF LABEL HAVE DIFFERENT EXPIRATION DATES. PROBLEM #2: PRODUCT LABEL USES SYMBOL ONLY TO INDICATE EXPIRATION DATE WITHOUT THE PRINTED ENGLISH WORDS "EXPIRATION DATE." ATTEMPTED TO CONTACT MFR WHO STATED "TAKE MY WORD, IT'S STERILE." WHEN QUESTIONED FURTHER STATED, "YOU CAN TAKE MY WORD OR NOT." ALSO STATED THAT THEY DID FURTHER TESTING INDICATING A LONGER STERILE DATE AND THE OUTER MOST LABEL IS THE CURRENT LABEL. PLEASE GIVE GUIDANCE ON THIS PRODUCT. REASON FOR USE: POST PARTUM HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226523 EBB COMPLETE TAMPONADE SYSTEM OQY GLENVEIGH MEDICAL 97667

    Patients

    Seq Age Sex Outcome Treatment
    1 EBB