BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POISE IMPRESSA : PESSARY, VAGINAL : HHW

    MDR report key: 10403410 · Received August 13, 2020

    Report

    Report Number
    3011109575-2020-01700
    Event Type
    Injury
    Date Received
    August 13, 2020
    Date of Event
    July 20, 2020
    Report Date
    August 13, 2020
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HHW
    UDI-DI
    00036000998450
    PMA / PMN Number
    K131198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    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 SUPPORTING RECORDS CAN BE PERFORMED. THE POISE IMPRESSA BLADDER SUPPORT PRODUCT LABELING STATES DO NOT USE BLADDER SUPPORT DURING SEXUAL INTERCOURSE. THE LABELING ALSO SPECIFIES TO NOT USE THE BLADDER SUPPORT MORE THAN 12 HOURS IN A 24 HOUR PERIOD. THE CONSUMER LEFT THE PRODUCT IN FOR 16 MONTHS AND HAD INTERCOURSE WHILE THE DEVICE WAS INSERTED.

    Description of Event or Problem · 1

    CONSUMER REPORTED A BLADDER SUPPORT WAS INADVERTENTLY RETAINED IN HER VAGINAL CAVITY FOR 16 MONTHS. ON (B)(6) 2019, THE CONSUMER INSERTED THE BLADDER SUPPORT. LATER THAT DAY, HER PREEXISTING PNEUMONIA SYMPTOMS WORSENED AND SHE WAS ADMITTED TO THE HOSPITAL. SHE WAS SEDATED, HAD A URINARY CATHETER INSERTED, AND WAS TREATED IN THE ICU. THE CONSUMER WAS HOSPITALIZED FOR APPROXIMATELY EIGHT DAYS. DURING HER HOSPITAL STAY AND SUBSEQUENT MONTHS AFTER, THE CONSUMER HAD FORGOTTEN SHE HAD INSERTED THE BLADDER SUPPORT. DURING THE SUMMER OF 2019, SHE BEGAN TO EXPERIENCE LIGHT PINK VAGINAL BLEEDING WHILE WIPING AND DARK RED VAGINAL BLEEDING DURING INTERCOURSE. IN (B)(6) 2019, SHE WAS SEEN BY HER HEALTHCARE PROVIDER AND DIAGNOSED WITH A YEAST INFECTION. AN UNSPECIFIED MEDICATION WAS PRESCRIBED BUT HER YEAST INFECTION NEVER FULLY RESOLVED. IN (B)(6) 2020, SHE BEGAN TO EXPERIENCE VAGINAL PAIN. IN (B)(6) 2020 SHE HAD A VAGINAL EXAM AND WAS DIAGNOSED WITH A BACTERIAL INFECTION AND PLACED ON ANTIBIOTICS. DURING THE VAGINAL EXAM, THE HEALTHCARE PROVIDER DISCOVERED A HARD FOREIGN MATERIAL IN HER VAGINAL CAVITY. A VAGINAL ULTRASOUND AND A CAT SCAN WERE PERFORMED WHICH CONFIRMED A FOREIGN OBJECT. ON (B)(6) 2020, A SPECIALIST PERFORMED A VAGINAL EXAM AND REMOVED THE FOREIGN MATERIAL WHICH WAS IDENTIFIED AS THE BLADDER SUPPORT. SHE EXPERIENCED PAIN UPON REMOVAL BUT THE PAIN IMPROVED AFTER IT WAS REMOVED. NO FURTHER MEDICAL TREATMENT WAS NEEDED. THE CONSUMER CONFIRMED THE STRING WAS INTACT UPON USE. SHE STATED THAT SHE FORGOT ABOUT USING THE PRODUCT BECAUSE OF THE NEED TO BE HOSPITALIZED FOR A PREEXISTING UNRELATED ILLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866595 POISE IMPRESSA : PESSARY, VAGINAL : HHW PESSARY, VAGINAL HHW K-C AFC MANUFACTURING, S. DE R.L. DE C.V SIZE 1 00036000998450

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention