BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD? LITE

    MDR report key: 4170019 · Received October 14, 2014

    Report

    Report Number
    3005099803-2014-03288
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 16, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTP
    PMA / PMN Number
    K122459
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):ACCORDING TO THE COMPLAINANT, THE DEVICE WAS DISPOSED OF AND IS NOT AVAILABLE FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE WITH CAPIO SLIM WAS USED DURING A VAULT PROLAPSE PROCEDURE PERFORMED ON (B)(6) 2014.ACCORDING TO THE COMPLAINANT, THE NEEDLE DETACHED INSIDE THE PATIENT WHEN THE SUTURE WAS BEING PLACED THROUGH THE SACROSPINOUS LIGAMENT. THE PHYSICIAN TRIED TO LOCATE THE NEEDLE BY PALPATION. HOWEVER, IT WAS NOT RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER UPHOLD LITE WITH CAPIO SLIM.THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651801 UPHOLD? LITE MESH, SURGICAL, SYNTHETIC OTP BOSTON SCIENTIFIC - MARLBOROUGH M0068318170

    Patients

    Seq Age Sex Outcome Treatment
    1 Other