BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 575241 · Received February 3, 2005

    Report

    Report Number
    MW1034687
    Event Type
    Other
    Date Received
    February 3, 2005
    Date of Event
    December 11, 2004
    Report Date
    February 2, 2005
    Manufacturer
    CARDINAL HEALTHCARE
    Product Code
    FOB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT STATED THAT AFTER BEING PLACED ON BEDPAN, IT BROKE - 7 CM LACERATION TO LEFT BUTTOCK. (MULTIPLE ISSUES WITH BEDPANS BREAKING UNDER SEVERAL PTS).

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 3/25/05: THIS PRODUCT IS MANUFACTURED BY MEDEGEN, LLC, 209 MEDEGEN DR., GALLAWAY, TN 38036. CARDINAL NEITHER MANUFACTURE NOR OWN THE REGULATORY PATHWAY FOR THIS PRODUCT. CARDINAL DISTRIBUTES THIS PRODUCT FOR MEDEGEN. CARDINAL HAS COPIED THEM ON REQUEST FOR INFO AND HAS ASKED THEM TO RESPOND BACK DIRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * BEDPAN FOB CARDINAL HEALTHCARE 13499-MAV 4120504

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other