BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POISE IMPRESSA : PESSARY, VAGINAL : HHW

    MDR report key: 14848200 · Received June 28, 2022

    Report

    Report Number
    3011109575-2022-00253
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    June 6, 2022
    Report Date
    June 28, 2022
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HHW
    UDI-DI
    00036000496208
    PMA / PMN Number
    K131198
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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

    CONSUMER REPORTED UPON REMOVAL THE STRING PULLED OUT OF A BLADDER SUPPORT LEAVING THE PESSARY INSIDE HER VAGINAL CAVITY. SHE WENT TO ER FOR REMOVAL OF THE PESSARY. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS AND DID NOT REQUIRE ANY FOLLOW-UP MEDICAL VISITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1938795 POISE IMPRESSA : PESSARY, VAGINAL : HHW PESSARY, VAGINAL HHW K-C AFC MANUFACTURING, S. DE R.L. DE C.V SIZE 3 NN118261A 00036000496208

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female