BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTIS SINGLE INCISION SLING SYSTEM

    MDR report key: 3832142 · Received February 12, 2014

    Report

    Report Number
    2125050-2014-00081
    Event Type
    Injury
    Date Received
    February 12, 2014
    Date of Event
    January 11, 2014
    Report Date
    February 11, 2014
    Manufacturer
    COLOPLAST A/S
    Product Code
    PAH
    PMA / PMN Number
    K121562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THIS REPORT.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, AFTER IMPLANTATION SURGERY NOTICES THAT THE TIP OF ONE OF THE INTRODUCERS WAS BROKEN. THE TIP WAS NOT RETRIEVED OR RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92058 ALTIS SINGLE INCISION SLING SYSTEM URINARY INCONTINENCE SLING PAH COLOPLAST A/S 5196501022 3560149

    Patients

    Seq Age Sex Outcome Treatment
    1 Other