BEUDAMED
    FDA Adverse Event Other Summary report: N

    LINVATEC 16L HIGH FLOW LAPAROFLATOR

    MDR report key: 273386 · Received April 10, 2000

    Report

    Report Number
    8043980-2000-00002
    Event Type
    Other
    Date Received
    April 10, 2000
    Date of Event
    March 6, 2000
    Report Date
    March 10, 2000
    Manufacturer
    WOM GMBH
    Product Code
    FCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC HERNIORRHAPHY, PT EXHIBITED SIGNS OF SUBCUTANEOUS EMPHYSEMA OF NECK AND JAW LINE. PT'S RESPIRATION WAS SPONTANEOUS AND UNLABORED AND PT WAS EXTUBATED AS EXPECTED. PT WAS DISCHARGED WITHOUT FURTHER COMPLICATIONS FROM EVENT AND NO TREATMENT WAS ADMINISTERED. SUBCUTANEOUS EMPHYSEMA RESOLVED ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINVATEC 16L HIGH FLOW LAPAROFLATOR INSUFFLATOR FCX WOM GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other