BEUDAMED
    FDA Adverse Event Death Summary report: N

    TUCKER MCLEAN FORCEPS

    MDR report key: 138110 · Received December 15, 1997

    Report

    Report Number
    2515651-1997-90002
    Event Type
    Death
    Date Received
    December 15, 1997
    Date of Event
    November 2, 1997
    Report Date
    November 13, 1997
    Manufacturer
    PILLING SURGICAL INSTRUMENTS
    Product Code
    HDA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    USE OF FORCEPS INDICATED AS MOTHER UNABLE TO PUSH EFFECTIVELY TO DELIVER INFANT. INFANT IN BIRTH CANAL & HAVING DECELERATIONS WITH CONTRACTIONS. INFANT WAS FACE UP. TUCKER MCLEAN FORCEPS INSERTED WITH DIFFICULTY, ON FIRST ATTEMPT FORCEPS SLIPPED, SECOND ATTEMPT NEONATAL DEATH RESULTED. THE PHYSICIAN TOLD FAMILY THAT HE HAD FRACTURED BABY'S SKULL WITH FIRST ATTEMPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUCKER MCLEAN FORCEPS FORCEPS HDA PILLING SURGICAL INSTRUMENTS * CC4

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Death