BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VESICA PERC STABILIZATIION KIT W/PROTEGEN

    MDR report key: 282132 · Received June 16, 2000

    Report

    Report Number
    6000043-2000-00018
    Event Type
    Injury
    Date Received
    June 16, 2000
    Date of Event
    December 23, 1998
    Report Date
    June 16, 2000
    Manufacturer
    MICROVASIVE UROLOGY/ A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT FOLLOWING A TRANSVAGINAL SLING PROCEDURE, THE PT COMPLAINED OF INFECTION, DRAINAGE AND DEHISCENCE. THE DEVICE WAS REMOVED ON 11/01/1999. THE DEVICE WAS NOT RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention