BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFR KIT ¿ UPHOLD LITE VAGINAL SUPPORT SYSTEM

    MDR report key: 2860937 · Received December 6, 2012

    Report

    Report Number
    3005099803-2012-05903
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE VAGINAL SUPPORT SYSTEM WAS USED DURING A PROLAPSE REPAIR PROCEDURE. THE PHYSICIAN ENCOUNTERED DIFFICULTY REMOVING THE SLEEVES FROM BOTH SIDES OF THE MESH ASSEMBLY, AND DURING REMOVAL, BOTH OF THE SLEEVES DETACHED, CAUSING THE MESH TO BE TOO TIGHT. THE PHYSICIAN BELIEVED THAT THE TACK WELDS WERE TOO STRONG AND DID NOT BREAK CORRECTLY TO RELEASE THE SLEEVES. REPORTEDLY, THE DETACHED SLEEVES FELL LOOSE INSIDE THE PATIENT AND WERE SUBSEQUENTLY RETRIEVED WITH HEMOSTATS. THE PHYSICIAN WAS ABLE TO LOOSEN THE MESH AND COMPLETE THE PROCEDURE WITH NO COMPLICATIONS TO THE PATIENT, WHO WAS FINE AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFR KIT ¿ UPHOLD LITE VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317170 ML00000905

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention