BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURE FIT

    MDR report key: 28607 · Received December 11, 1995

    Report

    Report Number
    MW1007911
    Event Type
    Other
    Date Received
    December 11, 1995
    Date of Event
    November 1, 1995
    Report Date
    December 8, 1995
    Manufacturer
    CONVATEC, DIV. OF E.R. SQUIBBS & SONS, INC.
    Product Code
    EXD
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    IRRIGATION SLEEVE DID NOT REMAIN ATTACHED TO THE FLEXIBLE FLANGE. THIS HAS HAPPENED WITH SEVERAL BOXES OF EACH PRODUCT PURCHASED IN TWO DIFFERENT STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURE FIT SURE FIT EXD CONVATEC, DIV. OF E.R. SQUIBBS & SONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other