BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5192 FRONTALIS SUSPENSION SET

    MDR report key: 204773 · Received December 18, 1998

    Report

    Report Number
    1047439-1998-00002
    Event Type
    Malfunction
    Date Received
    December 18, 1998
    Date of Event
    October 29, 1998
    Report Date
    December 9, 1998
    Manufacturer
    BECTON DICKINSON
    Product Code
    HNM
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A BILATERAL (BOTH EYES) FRONTALIS SLING WAS PERFORMED ON AN INFANT WITH CONGENITAL PTOSIS USING VISITEC PRODUCT 5192 (LOT 021098), FRONTALIS SUSPENSION SET. ON POST-OPERATIVE DAY ONE, THE INFANT HAD AN EXCELLENT POST-OPERATIVE APPEARANCE. HOWEVER, ON POST-OPERATIVE DAY THREE, THE MOTHER NOTED THAT THE LEFT EYE LID HAD DRAMATICALLY CHANGED POSITIONS. WHEN EXAMINED, IT WAS CONCLUDED THAT THE PTOSIS SLING HAD BROKEN AND THE BABY HAD COMPLETE PTOSIS (DROOPY EYE LID) AGAIN. THE SLING WAS REMOVED AND A SECOND FRONTALIS SUSPENSION SET WAS PLACED ON THE LEFT SIDE USING A DEVICE FROM THE SAME LOT 021098. AFTER 2 WEEKS POST-OPERATIVE, THE CHILD WAS DOING WELL. THE SURGEON REPORTED THAT SHE HAS PREVIOUSLY NEVER HAD A SINGLE DIFFICULTY WITH PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5192 FRONTALIS SUSPENSION SET Implant PTOSIS SLING HNM BECTON DICKINSON 5192 021098

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other