BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POISE IMPRESSA : PESSARY, VAGINAL : HHW

    MDR report key: 12051901 · Received June 23, 2021

    Report

    Report Number
    3011109575-2021-00265
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    May 27, 2021
    Report Date
    June 23, 2021
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HHW
    UDI-DI
    00036000496215
    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 NOTICED PRIOR TO USE THAT THE STRING WAS TOO SHORT ON HER BLADDER SUPPORT AND SHE DID NOT USE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948807 POISE IMPRESSA : PESSARY, VAGINAL : HHW PESSARY, VAGINAL HHW K-C AFC MANUFACTURING, S. DE R.L. DE C.V SIZE 3 NN020071D 00036000496215

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR