BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSORBENT COTTON ROLL

    MDR report key: 31733 · Received March 20, 1996

    Report

    Report Number
    MW4001140
    Event Type
    Malfunction
    Date Received
    March 20, 1996
    Report Date
    July 20, 1994
    Manufacturer
    MEGA MEDICAL PRODUCTS, INC.
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT APPEARS THAT THE DEPOT SYSTEM OR MFRS ARE MISLABELING A PRODUCT WITH THE NATIONAL STOCK NUMBER. THE ITEM IDENTIFIED IN ENCLOSURE 1 IS LABELLED WITH THE NATIONAL STOCK NUMBER INDICATED ON ENCLOSURE 2. HOWEVER, THE SPECIFICATIONS LISTED ON ENCLOSURE 1 MATCH THE CATALOG SPECIFICATIONS LISTED IN ENCLOSURE 3 FOR ANOTHER NATIONAL STOCK NUMBER (EXCEPT FOR THE UNIT OF MEASURE QUANTITY, WHICH MAY BE A CATALOGING ERROR). CUSTOMERS COMPLAIN THAT THE MATERIAL, IDENTIFIED BY ENCLOSURE 1 FOR THE SUBJECT NATIONAL STOCK NUMBER, CLOGS THEIR SUCTION DEVICES BECAUSE IT IS TOO SMALL. THEY THINK THEY ARE SUPPOSED TO GET MATERIAL WITH A HALF INCH DIAMETER AND THE MATERIAL IDENTIFIED BY ENCLOSURE 1 IS ONLY 3/8 INCH DIAMETER. ENCLOSURE 5 SHOWS A LABEL FROM A CORRECTLY MARKED BOX OF MATERIAL. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSORBENT COTTON ROLL COTTON ROLL 3/8 X 1 1/2" FRO MEGA MEDICAL PRODUCTS, INC. A-MDF-5/90-5

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO