BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POISE IMPRESSA

    MDR report key: 6948066 · Received October 13, 2017

    Report

    Report Number
    3011109575-2017-00076
    Event Type
    Injury
    Date Received
    October 13, 2017
    Date of Event
    June 1, 2017
    Report Date
    October 13, 2017
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HHW
    PMA / PMN Number
    K131198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURER LOT CODE WAS NOT PROVIDED. WITH NO MEANS TO ASCERTAIN THE MANUFACTURER/ASSET LINE AND DAY OF PRODUCTION, NO FURTHER INVESTIGATION ON DOCUMENTS AND RECORDS CAN BE PERFORMED. COMPLAINTS WHICH ARE SERIOUS IN NATURE ARE REVIEWED ON A REGULAR BASIS OR FOR DUE CAUSE TO PROVIDE VISIBILITY AND ESCALATION. IN ADDITION, ALL COMPLAINTS ARE ALSO MONITORED FOR TRENDING ON A MONTHLY CADENCE. INVESTIGATION IS CURRENTLY IN PROGRESS. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE CONSUMER STATED SHE USED AN UNKNOWN SIZE OF POISE IMPRESSA BLADDER SUPPORT PRODUCT AND REMOVED IT SHORTLY AFTER INSERTION DUE TO DISCOMFORT. THE CONSUMER EXPERIENCED VAGINAL PAIN AND AN INCREASE IN URINARY LEAKAGE. TWO TO THREE MONTHS LATER, THE CONSUMER SOUGHT MEDICAL ATTENTION AND A 5-6 CM CYLINDRICAL SMOOTH PLASTIC OBJECT WAS REMOVED. SHE EXPERIENCED A SMALL AMOUNT OF VAGINAL BLEEDING, INCREASED URINARY LEAKAGE AND WAS DIAGNOSED WITH URETHROVAGINAL FISTULA. ON THE WELLNESS CHECK ON (B)(6) 2017, THE CONSUMER STATED THAT SHE WAS DOING FINE AND GOING BACK TO HER UROLOGIST ON (B)(6) 2017. ON WELLNESS CHECK ON (B)(6) 2017, THE CONSUMER STATED SHE IS SCHEDULED TO HAVE THE URETHOVAGINAL FISTULA REPAIR ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728494 POISE IMPRESSA PESSARY, VAGINAL HHW K-C AFC MANUFACTURING, S. DE R.L. DE C.V

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention