BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIMPSON WILKART

    MDR report key: 245062 · Received October 14, 1999

    Report

    Report Number
    MW1017335
    Event Type
    Other
    Date Received
    October 14, 1999
    Date of Event
    September 27, 1999
    Report Date
    October 14, 1999
    Manufacturer
    SKLAR INSTRUMENT CO.
    Product Code
    HDA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ATTEMPTED VACUUM DELIVERY FAILED, THEREFORE FORCEPS DELIVERY CARRIED OUT. CEPHALOHEMATOMA NOTED AT DELIVERY. APGARS 2, 8. APNEIC EPISODES NOTED WITHIN 24 HOURS OF DELIVERY. HEAD ULTRASOUND 9/28 AND CT SCAN 9/29 NEGATIVE FOR INTRACRANIAL HEMORRHAGE. QUESTIONABLE SEIZURE ACTIVITY NOTED ALTHOUGH EEG 10/1 NEGATIVE FOR SEIZURES. REPEAT CT SCAN 10/3 REVEALED SMALL RIGHT SUBDURAL HEMORRHAGE. PHENOBARBITAL INITIATED 10/11/99 FOR SEIZURES. ACCORDING TO NEUROLOGY, PT CONDITION CONSISTENT WITH PROBABLE INTRAUTERINE INJURY AS OPPOSED TO BIRTH TRAUMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPSON WILKART DELIVERY FORCEPS HDA SKLAR INSTRUMENT CO. 14" FORCEPS *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Other