BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VESICA PERC STABILIZATION KIT

    MDR report key: 379330 · Received March 1, 2002

    Report

    Report Number
    6000043-2002-00018
    Event Type
    Injury
    Date Received
    March 1, 2002
    Report Date
    February 8, 2002
    Manufacturer
    MICROVASIVE UROLOGY/A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    FHK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUBSEQUENT TO A BLADDER SUSPENSION PROCEDURE, THE PATIENT WAS INJURED AND REQUIRED MEDICAL TREATMENT AND HOSPITALIZATION. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention