BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TODAY'S SPONGE

    MDR report key: 1413544 · Received July 7, 2009

    Report

    Report Number
    MW5011862
    Event Type
    Injury
    Date Received
    July 7, 2009
    Date of Event
    June 9, 2009
    Report Date
    July 7, 2009
    Manufacturer
    MAYER LABORATORIES
    Product Code
    LLR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TODAY'S SPONGE. I PURCHASED THE NEW TODAY'S SPONGE IN 2009. THE LOT NUMBER FOR THE PRODUCT IS 432457. I ATTEMPTED TO REMOVE THE SPONGE AFTER IT HAD BEEN INSERTED FOR APPROXIMATELY 8 HOURS. I WAS UNABLE TO REMOVE THE SPONGE AND HAD TO VISIT AN EMERGENCY ROOM FOR REMOVAL. THE PHYSICIAN ASSISTANT WHO REMOVED IT SAID THAT THE SPONGE HAD BEGUN TO DISINTEGRATE AND THE STRING WAS DETACHED AND WRAPPED AROUND THE SPONGE. I HAD USED THE SPONGE AS A BACKUP METHOD YEARS AGO AND I AM AWARE OF HOW TO INSERT AND REMOVE IT. I AM CONCERNED THAT THE PRODUCT BEGAN TO DISINTEGRATE DURING USAGE. DOSE OR AMOUNT: 1 SPONGE; FREQUENCY: AS NEEDED; ROUTE: VAG. DATES OF USE: 2009, 8 HOURS. DIAGNOSIS OR REASON FOR USE: BACK UP BIRTHCONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TODAY'S SPONGE SPONGE LLR MAYER LABORATORIES 432457

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Disability