BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DR FOG TREATED SPONGE, STERILE (40 EACH/ BOX)

    MDR report key: 5114838 · Received September 30, 2015

    Report

    Report Number
    1836161-2015-00080
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Date of Event
    July 31, 2015
    Report Date
    September 10, 2015
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    OCT
    PMA / PMN Number
    PK932449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REJECTED 7 PIECES DUE TO PACKING FAILURE. PRODUCT IS IN SEAL OF PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644196 DR FOG TREATED SPONGE, STERILE (40 EACH/ BOX) DR FOG TREATED SPONGE OCT ASPEN SURGICAL PRODUCTS, CALEDONIA DF-3120 68972

    Patients

    Seq Age Sex Outcome Treatment
    1