BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VESICA PERC STABILIZATION KIT W. PROTEGEN SLING

    MDR report key: 261083 · Received February 7, 2000

    Report

    Report Number
    6000043-2000-00002
    Event Type
    Injury
    Date Received
    February 7, 2000
    Date of Event
    December 15, 1998
    Report Date
    February 7, 2000
    Manufacturer
    MICROVASIVE UROLOGY A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SIX WEEKS AFTER PLACEMENT OF A PROTEGEN SLING THE PT EXPERIENCED SEVERE PAIN. EXAMINATION FOUND THAT THE SLING HAB BROKE THROUGH THE VAGINAL WALL. THE SLING WAS REMOVED IN 98. SEVERAL MONTHS LATER, THE PT DIDN'T FEEL WELL AND THE PHYSICIAN OBSERVED THAT THE PERMANENT SUTURES HAD ALSO PENETRATED THE VAGINAL WALL. A SECOND SURGERY WAS PERFORMED IN 1999 TO REMOVE THE SUTURES. NO PRODUCT WAS RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VESICA PERC STABILIZATION KIT W. PROTEGEN SLING PERC STABILIZATION KIT FTL MICROVASIVE UROLOGY A DIVISION OF BOSTON SCIENTIFIC CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention