BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POISE IMPRESSA : PESSARY, VAGINAL : HHW

    MDR report key: 12682275 · Received October 22, 2021

    Report

    Report Number
    3011109575-2021-00622
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Date of Event
    August 28, 2021
    Report Date
    October 22, 2021
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HHW
    UDI-DI
    00036000998474
    PMA / PMN Number
    K131198
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    CONSUMER REPORTED UPON REMOVAL THE STRING BROKE OFF OF THE BLADDER SUPPORT LEAVING THE PESSARY INSIDE HER VAGINAL CAVITY. SHE WAS UNABLE TO REMOVE THE PESSARY ON HER OWN. SHE WENT TO THE EMERGENCY ROOM AND THE PESSARY WAS REMOVED USING A SPECULUM AND FORCEPS. WITH REMOVAL SHE EXPERIENCED VAGINAL PAIN AND BLEEDING. HER SYMPTOMS RESOLVED A WEEK AFTER THE BLADDER SUPPORT WAS REMOVED. SHE DID NOT RECEIVE ADDITIONAL MEDICAL TREATMENT. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1581342 POISE IMPRESSA : PESSARY, VAGINAL : HHW PESSARY, VAGINAL HHW K-C AFC MANUFACTURING, S. DE R.L. DE C.V SIZE 3 NN005961A 00036000998474

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR