BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROVATE DEVICE

    MDR report key: 21775539 · Received April 4, 2025

    Report

    Report Number
    MW5168632
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    April 2, 2025
    Report Date
    September 2, 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

    ADDITIONAL INFORMATION RECEIVED FOR REPORT NO. MW5168632 ON 9/02/2025. SUPPLEMENTAL UPDATE FOR MEDWATCH (B)(4). MEDWATCH REPORT (B)(4) WAS INADVERTENTLY SUBMITTED TO FDA BY A SUBCONTRACTOR CALL CENTER WHILE DOCUMENTING A COMPLAINT INTENDED FOR THE MANUFACTURER. THE CASE INVOLVES AN 81-YEAR-OLD FEMALE WHO USED PROVATE SIZE 73 FOR APPROXIMATELY 12 DAYS. DURING FOLLOW UP WITH THE PATIENT'S CLINIC, ADDITIONAL DETAILS SURROUNDING THE COMPLAINT: THE PATIENT'S MEDICAL RECORD CONFIRMED A DIAGNOSIS OF DRY ATROPHIC VAGINA, WHICH IS LISTED IN DEVICE LABELING AS A CONTRAINDICATION. DURING THIS PERIOD, THE PATIENT WAS ALSO USING A REUSABLE TRADITIONAL RING PESSARY (BRAND UNKNOWN). SHE REPORTED TO THE CLINIC'S HEALTH CARE PROVIDER THAT SHE WAS EXPERIENCING SPOTTING WITH SCANT BLOOD BUT NO PAIN. CLINICAL EXAM FINDINGS SHOWED NO TEARS OR DAMAGE, ONLY SPOTTING. THE MANUFACTURER DETERMINED THE EVENT IS NOT REPORTABLE, NOT SERIOUS, AND DID NOT REQUIRE MEDICAL INTERVENTION. BECAUSE TWO DEVICES WERE IN USE CONCURRENTLY, ATTRIBUTION OF THE SYMPTOMS COULD NOT BE ESTABLISHED. A CODING UPDATE HAS BEEN MADE TO DELETE HEALTH EFFECT CLINICAL CODES 1888 (HEMORRHAGE/BLOOD LOSS/BLEEDING) AND 4559 (UNSPECIFIED TISSUE INJURY). THE HEALTH EFFECT IMPACT CODE IS (B)(4), AND THE MEDICAL DEVICE PROBLEM CODE IS 2993. ON (B)(6) 2025, THE PATIENT WAS SEEN FOR A REFIT, INSTRUCTED TO REPLACE THE DEVICE WEEKLY, AND ADVISED TO USE PREMARIN VAGINAL CREAM; NO BLEEDING WAS REPORTED AT THAT TIME. ON (B)(6) DURING A PHONE CALL, THE PATIENT REPORTED SATISFACTION WITH THE DEVICE AND NO PAIN, THOUGH SOME SPOTTING PERSISTED, AND SHE WAS ADVISED TO ADD REPLENS. ON (B)(6), DURING AN OFFICE VISIT, SHE REMAINED SATISFIED WITH THE DEVICE SUPPORT BUT REPORTED INTERMITTENT SPOTTING AFTER INSERTION; SCANT BLEEDING WAS NOTED ON SPECULUM EXAM. AT THIS TIME, SHE WAS USING BOTH REPLENS AND PREMARIN, THE DEVICE WAS REMOVED FOR PELVIC REST, AND SURGERY WAS DISCUSSED AS A FUTURE OPTION. ON (B)(6), A PHYSICIAN RE-INTRODUCED PROVATE, BUT SPOTTING OCCURRED UPON REMOVAL. THE PATIENT WAS SWITCHED TO AN OPEN RING PESSARY, AND SURGICAL OPTIONS REMAIN UNDER CONSIDERATION. PATIENT CODE: 2665.

    Description of Event or Problem · 0

    THE PATIENT EXPERIENCED IRRITATION AND THE PRODUCT TORE HER VAGINAL WALL. SHE BEGAN BLEEDING FOR A FEW DAYS. PRODUCT NAME: CONTIPI PROVATE; THERAPY START DATE: (B)(6) 2025, THERAPY END DATE: (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730691 PROVATE DEVICE PESSARY, VAGINAL HHW CONTIPI MEDICAL LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Other PREMARIN VAGINAL CREAM. | REPLENS.| REUSABLE TRADITIONAL RING PESSARY (BRAND UNKNOWN).