BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROVATE 85 MG

    MDR report key: 23437074 · Received October 31, 2025

    Report

    Report Number
    MW5178361
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    October 16, 2025
    Report Date
    October 28, 2025
    Manufacturer
    CONTIPI MEDICAL LTD
    Product Code
    HHW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT'S HEALTH CARE PROVIDER PUT A SAMPLE OF 88MM OF CONTIPI IN THE PATIENT AND IT CAUSED HER HARM AND TO BLEED. PATIENT CANNOT TAKE THIS UNTIL SHE HAS HEALED. PATIENT MENTIONED THAT SHE WILL NOT BE TAKING THE 85MM, BUT HER HEALTH CARE PROVIDER WILL BE PRESCRIBING THE 79MM FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1894942 PROVATE 85 MG PESSARY, VAGINAL HHW CONTIPI MEDICAL LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female