BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAM

    MDR report key: 524749 · Received February 6, 2004

    Report

    Report Number
    524749
    Event Type
    Malfunction
    Date Received
    February 6, 2004
    Date of Event
    December 1, 2003
    Report Date
    December 1, 2003
    Manufacturer
    TARRY MANUFACTURING
    Product Code
    MEF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS DEFECT WAS RECOGNIZED PRIOR TO DELIVERY TO THE PT AREA. STERILE PACKAGING HAD BEEN PERFORATED ON 41 INDIVIDUAL PACKAGES. USER IS CONFIDENT THAT THE PRODUCT HAS COME IN FROM MFR IN THIS CONDITION. THE PACKAGING OF EACH OF THE 41 UNITS HAD BEEN PERFORATED; MOST APPEARED TO HAVE BEEN SLICED - AS IF BY A KNIFE. USER SUSPECTS - BUT DOSE NOT KNOW - THAT THIS HAPPENED IN THE MFR'S PACKAGING PROCESS. CO HAS NOTIFIED THE MFR. USER WILL SHIP THE DEFECTIVE PRODUCT TO THE MFR - PROBABLY ON 12/2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAM INFANT PACIFIER MEF TARRY MANUFACTURING 521 STERILE 11Z2

    Patients

    Seq Age Sex Outcome Treatment
    1 *