BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMNIHOOK AMNIOTIC MEMBRANE

    MDR report key: 3244599 · Received January 14, 2013

    Report

    Report Number
    1219232-2012-00009
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 6, 2012
    Report Date
    January 11, 2013
    Manufacturer
    HOLLISTER INC
    Product Code
    HGE
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO INFANTS WERE FOUND WITH 1/4" TO 1/2" LONG SCABBED LACERATIONS OF THEIR SCALP. BOTH INFANTS WERE BORN TO MOTHERS WHO HAD AMNIOTOMIES PERFORMED WITH AMNIHOOKS AND NO INTERNAL MONITORING. THESE LACERATIONS WERE SIGNIFICANT AND ASSESSED THROUGHOUT HOSPITALIZATION BY THE COVERING PEDIATRICIAN. THE OCCURRENCES WERE WITH TWO DIFFERENT DOCTORS. A RETURNED SAMPLE WAS INSPECTED BY THE MFR, DURING WHICH IT WAS DETERMINED THAT THE UNIT WAS NORMAL AND FUNCTION. DURING MANUFACTURE, THE UNITS ARE 100% INSPECTED FOR POTENTIAL ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21874 AMNIHOOK AMNIOTIC MEMBRANE AMNIHOOK HGE HOLLISTER INC D9601 2D04

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA