BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VESSICA KIT WITH PROTEGEN SLING

    MDR report key: 271894 · Received April 4, 2000

    Report

    Report Number
    6000048-2000-00014
    Event Type
    Injury
    Date Received
    April 4, 2000
    Date of Event
    February 21, 2000
    Manufacturer
    MICROVASIVE UROLOGY A DIV OF BOSTON SCIENTIFIC CORP.
    Product Code
    FHK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO YEARS FOLLOWING A SLING PLACEMENT, THE PT DEVELOPED AN INFECTION WHICH NECESSITATED THE REMOVAL OF THE SLING. THERE IS NO FURTHER INFO AND THE PRODUCT HAS NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN VESSICA KIT WITH PROTEGEN SLING PERC STABILIZATION KIT FHK MICROVASIVE UROLOGY A DIV OF BOSTON SCIENTIFIC CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention