BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIERPRO VAGINAL SPECULUM, LIGHTED, STERILE, SIZE LARGE

    MDR report key: 16521394 · Received March 10, 2023

    Report

    Report Number
    16521394
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    March 6, 2023
    Report Date
    March 7, 2023
    Manufacturer
    SVS LLC
    Product Code
    HIB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    LIGHTS ON OUR LARGE LIGHTED SPECULUMS ARE NOT BRIGHT ENOUGH TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845189 PREMIERPRO VAGINAL SPECULUM, LIGHTED, STERILE, SIZE LARGE SPECULUM, VAGINAL, NONMETAL HIB SVS LLC 5342 CBEI 08-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown