BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POISE IMPRESSA : PESSARY, VAGINAL : HHW

    MDR report key: 11985016 · Received June 11, 2021

    Report

    Report Number
    3011109575-2021-00212
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Date of Event
    May 15, 2021
    Report Date
    June 11, 2021
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HHW
    UDI-DI
    00036000465600
    PMA / PMN Number
    K131198
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORD (DHR) AND SUPPORTING QUALITY RECORDS CONFIRMED NO ANOMALIES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE MALFUNCTION.

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT AFTER SHE WORE A BLADDER SUPPORT FOR APPROXIMATELY 12 HOURS, THE STRING BROKE OFF DURING REMOVAL LEAVING THE PESSARY INSIDE HER VAGINAL CAVITY. SHE WAS UNABLE TO MANUALLY REMOVE THE PESSARY. SHE STATED THAT HER HUSBAND WHO IS A NURSE USED FORCEPS TO REMOVE THE BLADDER SUPPORT. SHE DID NOT SEEK ANY ADDITIONAL MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883439 POISE IMPRESSA : PESSARY, VAGINAL : HHW PESSARY, VAGINAL HHW K-C AFC MANUFACTURING, S. DE R.L. DE C.V SIZE 3 NN807571A 00036000465600

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR