BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD¿ LITE

    MDR report key: 6215198 · Received December 30, 2016

    Report

    Report Number
    3005099803-2016-03932
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Date of Event
    December 6, 2016
    Report Date
    December 6, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTP
    PMA / PMN Number
    K122459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. ASSOCIATED MFR REPORT #3005099803-2016-03933 PERTAINS TO THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD¿ LITE WAS USED DURING AN ANTERIOR REPAIR PROCEDURE ON (B)(6) 2016. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE AND IT WAS FOUND INSIDE THE CAPIO CAGE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO ANY PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865866 UPHOLD¿ LITE MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN OTP BOSTON SCIENTIFIC - MARLBOROUGH M0068318170

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR