BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POISE IMPRESSA : PESSARY, VAGINAL : HHW

    MDR report key: 14213561 · Received April 26, 2022

    Report

    Report Number
    3011109575-2022-00165
    Event Type
    Malfunction
    Date Received
    April 26, 2022
    Date of Event
    March 30, 2022
    Report Date
    April 26, 2022
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HHW
    UDI-DI
    00036000496185
    PMA / PMN Number
    K131198
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 INSERTION OF A BLADDER SUPPORT SHE FELT PAIN DUE TO BEING SCRATCHED FROM THE PETALS ON THE APPLICATOR THAT WERE SLIGHTLY OPEN DURING INSERTION. THE PAIN RESOLVED LATER THAT DAY. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT EXPERIENCE ANY SERIOUS ADVERSE HEALTH EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1590176 POISE IMPRESSA : PESSARY, VAGINAL : HHW PESSARY, VAGINAL HHW K-C AFC MANUFACTURING, S. DE R.L. DE C.V SIZE 1 NN029671A 00036000496185

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female