BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POISE IMPRESSA : PESSARY, VAGINAL : HHW

    MDR report key: 23255591 · Received October 9, 2025

    Report

    Report Number
    3011109575-2025-00059
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 11, 2025
    Report Date
    October 9, 2025
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HHW
    PMA / PMN Number
    K131198
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RECORDS DEMONSTRATE THAT THE FINISHED PRODUCT WAS PRODUCED ACCORDING TO SPECIFICATIONS, MET ALL QUALITY ACCEPTANCE CRITERIA FOR PRODUCT RELEASE, AND QUALITY SYSTEM PROCEDURES WERE CORRECTLY FOLLOWED.

    Description of Event or Problem · 0

    CONSUMER REPORTED UPON ATTEMPTED REMOVAL OF A SIZE 1 PESSARY, THE STRING SEPARATED FROM IT. SHE MANUALLY REMOVED THE BLADDER SUPPORT FROM HER VAGINAL CAVITY. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT REPORT ANY ADVERSE HEALTH EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2574302 POISE IMPRESSA : PESSARY, VAGINAL : HHW PESSARY, VAGINAL HHW K-C AFC MANUFACTURING, S. DE R.L. DE C.V PESSARY NN503071A

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female