BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POISE IMPRESSA : PESSARY, VAGINAL : HHW

    MDR report key: 19963419 · Received August 12, 2024

    Report

    Report Number
    3011109575-2024-00069
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    July 9, 2024
    Report Date
    August 12, 2024
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HHW
    UDI-DI
    00036000496192
    PMA / PMN Number
    K131198
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RECORDS DEMONSTRATE THAT QUALITY SYSTEM PROCEDURES WERE CORRECTLY FOLLOWED AND THE FINISHED PRODUCT MET ALL QUALITY RELEASE CRITERIA AND SPECIFICATIONS WERE WITHIN ALLOWABLE LIMITS PRIOR TO RELEASE.

    Description of Event or Problem · 0

    REPORT 2 OF 2. CONSUMER REPORTED UPON ATTEMPTED REMOVAL OF A PESSARY, THE STRING WAS SEPARATED FROM THE BLADDER SUPPORT. SHE WAS UNSURE IF IT SEPARATED WHEN SHE PULLED ON IT FOR REMOVAL OR IF IT SEPARATED DURING WEAR. SHE MANUALLY REMOVED THE BLADDER SUPPORT FROM HER VAGINAL CAVITY. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2027312 POISE IMPRESSA : PESSARY, VAGINAL : HHW PESSARY, VAGINAL HHW K-C AFC MANUFACTURING, S. DE R.L. DE C.V SIZE 2 NN401171A1602 00036000496192

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female