BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREP SPONGE STICK 2 X 2 X 1, 8"

    MDR report key: 18558 · Received December 28, 1994

    Report

    Report Number
    MW1004584
    Event Type
    Malfunction
    Date Received
    December 28, 1994
    Date of Event
    October 17, 1994
    Report Date
    December 14, 1994
    Manufacturer
    SEAMLESS PROFESSIONAL MEDICAL PRODUCTS, INC.
    Product Code
    HGD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    YELLOW PREP SPONGE RETAINED IN VAGINA AFTER SPONGE SLIPPED OFF STICK. OTHER PREP SPONGES FROM THIS MFR WERE EXAMINED AND FOUND TO BE LOOSE ON STICK AND EASILY SLIPPED OFF. PT PRESENTED TO PHYSICIAN ON 12/12/94 WITH RETAINED SPONGE. SPONGE REMOVED WITHOUT INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREP SPONGE STICK 2 X 2 X 1, 8" PREP SPONGE STICK HGD SEAMLESS PROFESSIONAL MEDICAL PRODUCTS, INC. 44082392

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Other