BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFR KIT ¿ UPHOLD LITE VAGINAL SUPPORT SYSTEM

    MDR report key: 2973013 · Received February 21, 2013

    Report

    Report Number
    3005099803-2013-01109
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    January 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE VAGINAL SUPPORT SYSTEM WAS USED DURING AN ANTERIOR REPAIR PROCEDURE SOMETIME AROUND (B)(6) 2013. AS THE PHYSICIAN WAS TENSIONING THE MESH LEGS FOLLOWING THE SLEEVE REMOVAL, BOTH MESH LEGS TORE COMPLETELY OFF FROM THE MESH BODY, OUTSIDE THE PATIENT. THE PHYSICIAN REMOVED THIS UPHOLD DEVICE FROM THE PATIENT AND COMPLETED THE PROCEDURE BY DOING A STANDARD REPAIR WITH SUTURES. THERE WERE NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY OVER 18 YEARS OF AGE AND WAS FINE AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77095 PFR KIT ¿ UPHOLD LITE VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317170

    Patients

    Seq Age Sex Outcome Treatment
    1