BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE

    MDR report key: 15788115 · Received November 14, 2022

    Report

    Report Number
    3005099803-2022-06598
    Event Type
    Injury
    Date Received
    November 14, 2022
    Date of Event
    October 17, 2022
    Report Date
    November 14, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. REPORT SOURCE: OTHER: MHRA ADVERSE INCIDENT REPORT REFERENCE NO 2022/009/001/291/001; SUBMITTED TO MHRA (MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY) BY THE HEALTHCARE FACILITY. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PINNACLE, ANTERIOR DEVICE WAS USED DURING A PROCEDURE PERFORMED FOR THE TREATMENT OF PROLAPSE. THE PATIENT EXPERIENCED ANTERIOR MESH PINNACLE EXPOSURE, INFECTION AND CHRONIC PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1783716 PINNACLE MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN OTP BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention