BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD¿ LITE

    MDR report key: 6243927 · Received January 11, 2017

    Report

    Report Number
    3005099803-2016-04138
    Event Type
    Injury
    Date Received
    January 11, 2017
    Date of Event
    October 15, 2016
    Report Date
    December 20, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTP
    UDI-DI
    08714729839200
    PMA / PMN Number
    K122459
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE COMPLAINANT INDICATED THAT THE DEVICE IS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD (TM) LITE W/ CAPIO SLIM WAS USED DURING PELVIC FLOOR RECONSTRUCTION WITH UPHOLD LITE PROCEDURE ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2016, THE SUBJECT EXPERIENCED A URINARY TRACT INFECTION AND WAS TREATED WITH AZO, MACROBID, AND CEFTIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26447 UPHOLD¿ LITE MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN OTP BOSTON SCIENTIFIC - MARLBOROUGH M0068318170 ML00002025 08714729839200

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention