BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUKART-SIMPSON OB FCPS, SOLID

    MDR report key: 705514 · Received April 26, 2006

    Report

    Report Number
    1423507-2006-00051
    Event Type
    Other
    Date Received
    April 26, 2006
    Date of Event
    March 28, 2006
    Manufacturer
    CARDINAL HEALTH
    Product Code
    HDA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SHAFT BROKE IN HALF DURING SURGERY. THE ACCOUNT STATED THE DR WAS PULLING THE BABY OUT WHEN THE FORCEPS BROKE. THE DR COMPLETED THE DELIVERY WITHOUT THE USE OF ANOTHER FORCEPS AND WITHOUT INCIDENT. THE ACCOUNT FURTHER STATED MED OR SURGICAL INTERVENTION WAS NOT REQUIRED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUKART-SIMPSON OB FCPS, SOLID OBSTERICAL FORCEPS HDA CARDINAL HEALTH GL5540-4 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other