BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYSTIC II

    MDR report key: 1080869 · Received June 12, 2008

    Report

    Report Number
    1216677-2008-00014
    Event Type
    Injury
    Date Received
    June 12, 2008
    Product Code
    HDB
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT AVAILABLE. NO LOT INFO IS AVAILABLE. CUP SEPARATION IS TYPICALLY THE RESULT OF EXERTING A TWISTING MOTION TO THE DEVICE. THE DEVICE IS DESIGNED TO WITHSTAND 20 KG OF PULL FORCE BASED ON CURRENT OBSTETRICAL LITERATURE INDICATING 98% OF VACUUM ASSISTED DELIVERIES ARE ACHIEVED WITH LESS THAN 13.5 KG OF PULL FORCE. THE DEVICE SHOULD NEVER BE ACTIVELY TWISTED TO ROTATE THE HEAD AS FETAL INJURY MAY OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYSTIC II HDB

    Patients

    Seq Age Sex Outcome Treatment
    1