BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    REVIVE REUSABLE BLADDER SUPPORT

    MDR report key: 21146119 · Received January 13, 2025

    Report

    Report Number
    3015417614-2025-00001
    Event Type
    Injury
    Date Received
    January 13, 2025
    Date of Event
    November 17, 2024
    Report Date
    January 8, 2025
    Manufacturer
    RINOVUM SUBSIDIARY 2, LLC
    Product Code
    HHW
    UDI-DI
    00854389008009
    PMA / PMN Number
    K183468
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT IS UNKNOWN WHETHER OR NOT THE DEVICE CAUSED THE ISSUE; HOWEVER THE DEVICE WAS BEING USED DURING THE TIME THE EVENT OCCURRED. IT SEEMS UNLIKELY THAT A VAGINAL DEVICE WOULD LEAD TO A PERINEAL HEMATOMA SINCE THE DEVICE IS NOT INTENDED TO COME INTO CONTACT WITH THE PERIANAL OR ANAL SPACE. THE EVENT REQUIRED MEDICAL INTERVENTION. THEREFORE, WE ARE REPORTING IN COMPLIANCE WITH MDR REQUIREMENTS. RISK ASSESSMENT WAS DETERMINED NOT TO BE IMPACTED, BUT THIS AE WILL BE TRENDED. THIS IS AN ISOLATED EVENT THAT APPEARS AT THIS TIME TO BE AN ANOMALY.

    Description of Event or Problem · 0

    PATIENT WENT TO THE EMERGENCY ROOM DUE TO EXPERIENCING BLEEDING AND PAIN. SHE WAS DIAGNOSED WTIH A PERINEUM HEMATOMA, WHICH THE PHYSICICAN CONTRIBUTED TO THE BLEEDING THAT I EXPERIENCED FROM WEARING THE DEVICE 2 WEEKS AGO. THE PATIENT INDICATED THAT SHE ALSO EXPEREIENCED A URINARY TRACT INFECTION WHICH OCCURED AFTER THE FIRST COUPLE OF USES. THE LAST TIME SHE USED THE PRODUCT WAS 2 WEEKS PRIOR TO THE INCIDENT.·

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2179869 REVIVE REUSABLE BLADDER SUPPORT VAGINAL PESSARY HHW RINOVUM SUBSIDIARY 2, LLC 0025 109474509 00854389008009

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention