BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFR KIT ¿ UPHOLD LITE VAGINAL SUPPORT SYSTEM

    MDR report key: 3071467 · Received April 22, 2013

    Report

    Report Number
    3005099803-2013-02869
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN ANTERIOR REPAIR PROCEDURE USING AN UPHOLD LITE VAGINAL SUPPORT SYSTEM, THE PHYSICIAN PUT THE LEG ASSEMBLY OF THE UPHOLD ON THE PATIENT'S LEFT SIDE THROUGH THE BLADDER. THE PHYSICIAN REPAIRED THE PERFORATION WITH TWO LAYERS OF VICRYL SUTURES AND MADE SURE TO CLOSE IT VERY WELL. THE PROCEDURE WAS COMPLETED WITH THIS UPHOLD LITE VAGINAL SUPPORT SYSTEM WITH NO FURTHER COMPLICATIONS TO THE PATIENT, WHO WAS FINE AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171596 PFR KIT ¿ UPHOLD LITE VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317170 ML00001014

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention