BEUDAMED
    FDA Adverse Event Other Summary report: N

    MITYVAC M-STYLE MUSHROOM CUP

    MDR report key: 1140347 · Received August 26, 2008

    Report

    Report Number
    1140347
    Event Type
    Other
    Date Received
    August 26, 2008
    Date of Event
    May 14, 2008
    Report Date
    August 25, 2008
    Manufacturer
    COOPERSURGICAL
    Product Code
    HDB
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MD ATTEMPTED DELIVERY WITH MITYVAC APPLICATION. MITYVAC APPLIED X 1 UTERINE CONTRACTION. ATTEMPTED TO DELIVER INFANT WITH 3RD MATERNAL PUSH AND WITH 3RD PULL BY MD, STEM BROKE AT INSERTION SITE LOCATED IN CENTER OF MITY VAC CUP. NO POP-OFF'S OF MITYVAC NOTED DURING ATTEMPTS AT DELIVERY. DECISION MADE FOR PRIMARY C-SECTION. NO APPARENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITYVAC M-STYLE MUSHROOM CUP MITYVAC HDB COOPERSURGICAL 64279

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR