BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POISE IMPRESSA : PESSARY, VAGINAL : HHW

    MDR report key: 11983386 · Received June 11, 2021

    Report

    Report Number
    3011109575-2021-00208
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Date of Event
    May 13, 2021
    Report Date
    June 11, 2021
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HHW
    UDI-DI
    00036000998467
    PMA / PMN Number
    K131198
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 UPON REMOVAL THE STRING BROKE LEAVING THE BLADDER SUPPORT INSIDE HER VAGINAL CAVITY. SHE SOUGHT MEDICAL ATTENTION FOR REMOVAL OF THE BLADDER SUPPORT WHICH HAD BEEN INSIDE HER VAGINAL CAVITY FOR 16 HOURS BEFORE THE DOCTOR REMOVED IT. AN ULTRASOUND WAS PERFORMED TO ENSURE NOTHING REMAINED INSIDE. SHE EXPERIENCED DISCOMFORT WHICH RESOLVED AFTER THE DEVICE WAS REMOVED. SHE DID NOT RECEIVE ANY ADDITIONAL MEDICAL TREATMENT AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883355 POISE IMPRESSA : PESSARY, VAGINAL : HHW PESSARY, VAGINAL HHW K-C AFC MANUFACTURING, S. DE R.L. DE C.V SIZE 2 NN005571A 00036000998467

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR