BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICHOICE MALL LIGHTED SPECULUM

    MDR report key: 20373025 · Received October 3, 2024

    Report

    Report Number
    MW5160654
    Event Type
    Malfunction
    Date Received
    October 3, 2024
    Date of Event
    September 24, 2024
    Report Date
    September 30, 2024
    Manufacturer
    UNKNOWN
    Product Code
    FXF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE HAVING A PELVIC EXAM WITH A PLASTIC SPECULUM THE PATIENT SUFFERED A SMALL SUPERFICIAL AVULSION TYPE INJURY TO HER CERVIX. BLEEDING WAS CONTROLLED WITH MONSELS AND THE PATIENT WAS RELEASED TO GO HOME. THE SPECULUM WAS A MEDICHOICE SMALL LIGHTED SPECULUM LOT NUMBER 54167. THE SPECULUM AND THE BAG IT CAME IN WAS PLACED IN A BIOHAZARD BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53760 MEDICHOICE MALL LIGHTED SPECULUM SPECULUM, ILLUMINATED FXF UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Other