BEUDAMED
    FDA Adverse Event Summary report: N

    OBSTIHOOK

    MDR report key: 876853 · Received June 7, 2007

    Report

    Report Number
    876853
    Date Received
    June 7, 2007
    Date of Event
    April 27, 2007
    Report Date
    June 7, 2007
    Manufacturer
    INNOVATIVE MEDICAL PRODUCTS, LLC
    Product Code
    HGE
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT DELIVERY BABY WAS NOTED TO HAVE THREE SCRATCH MARKS ON THE RIGHT CHEEK. MOTHER HAD ARTIFICIAL RUPTURE OF MEMBRANES BY HER OB WITH THE OBSTIHOOK AMNIOTIC MEMBRANE PERFORATOR PRIOR TO DELIVERY. NO INTERNAL MONITORS WERE USED. DELIVERY WAS EASY. CAUSE OF SCRATCH MARKS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBSTIHOOK AMNIOTIC MEMBRANE PERFORATOR HGE INNOVATIVE MEDICAL PRODUCTS, LLC * 1033

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA NO OTHER THERAPIES