BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POISE IMPRESSA : PESSARY, VAGINAL : HHW

    MDR report key: 10115566 · Received June 3, 2020

    Report

    Report Number
    3011109575-2020-01657
    Event Type
    Malfunction
    Date Received
    June 3, 2020
    Date of Event
    May 9, 2020
    Report Date
    June 3, 2020
    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
    CA
    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

    THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER REPORTED SHE HAD A BLADDER SUPPORT THAT WAS MISSING THE STRING. SHE NOTICED PRIOR TO INSERTION AND DID NOT USE THE BLADDER SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580300 POISE IMPRESSA : PESSARY, VAGINAL : HHW PESSARY, VAGINAL HHW K-C AFC MANUFACTURING, S. DE R.L. DE C.V SIZE 3 NN834871A 00036000998474

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR