BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2842568 · Received November 21, 2012

    Report

    Report Number
    3005099803-2012-05360
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 31, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD VAGINAL SUPPORT SYSTEM WAS USED DURING A CYSTOCELE REPAIR AND ANTERIOR MESH PLACEMENT PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN WAS DISSATISFIED WITH THE PLACEMENT OF THE FIRST LEG ASSEMBLY IN THE LEFT LIGAMENT, SO HE WITHDREW IT THREE TIMES. HE WAS SATISFIED WITH THE PLACEMENT ON THE FOURTH THROW, BUT AS HE WAS PULLING THE LEG ASSEMBLY ALL THE WAY THROUGH THE LIGAMENT AND THE MESH WAS ALMOST IN POSITION, THE SUTURE, WITH THE NEEDLE AT THE END, DETACHED FROM THE DILATOR AT THE INCISION, AND THE PHYSICIAN WAS ABLE TO JUST PULL IT OUT OF THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER UPHOLD VAGINAL SUPPORT SYSTEM, WITH NO COMPLICATIONS TO THE PATIENT, WHO WAS OK AND STABLE AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080 ML00000314

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other