BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMFORT WEAR

    MDR report key: 452311 · Received March 26, 2003

    Report

    Report Number
    1062379-2003-00001
    Event Type
    Death
    Date Received
    March 26, 2003
    Date of Event
    February 7, 2003
    Report Date
    March 24, 2003
    Manufacturer
    THE MARENA GROUP, INC.
    Product Code
    MDR
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPANY RECEIVED A SUMMONS CLAIMING THAT THEIR GARMENT CAUSED THE DEATH OF PATIENT WHO HAD UNDERGONE LIPOSUCTION. THE GARMENT WAS SOLD BY DISTRIBUTER TO MEDICAL CENTER AND PRESCRIBED BY DR. COMPANY HAS NO FURTHER INFORMATION. FACILITY STOCKED SEVERAL BRANDS OF COMPRESSION GARMENTS AND COMPANY IS NOT 100% CERTAIN COMPANY MANUFACTURED THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMFORT WEAR FEMALE GIRDLE MDR THE MARENA GROUP, INC. LGS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death