BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VESICA PERC STABILIZATION KIT WITH PROTEGEN SLING

    MDR report key: 515388 · Received March 11, 2004

    Report

    Report Number
    6000043-2004-00014
    Event Type
    Injury
    Date Received
    March 11, 2004
    Date of Event
    November 30, 2003
    Report Date
    January 28, 2004
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    FHK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUBSEQUENT TO THE IMPLANT OF A PROTEGEN SLING FOR TREATMENT IN 1998, THE PT BEGAN EXPERIENCING PAIN, DISCHARGE, ODOR, AND ULCERS IN NOVEMBER OF 2003. AFTER CONDITION WORSENED, THE SLING WAS REMOVED IN 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VESICA PERC STABILIZATION KIT WITH PROTEGEN SLING PERC STABILIZATION KIT FHK BOSTON SCIENTIFIC CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention