BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENA PROTECTIVE UNDERWEAR

    MDR report key: 1398381 · Received February 27, 2009

    Report

    Report Number
    1039577-2009-00001
    Event Type
    Death
    Date Received
    February 27, 2009
    Date of Event
    May 27, 2007
    Report Date
    February 27, 2009
    Manufacturer
    SCA PERSONAL CARE, INC
    Product Code
    EYQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGED INCIDENT IS AN UNUSUAL EVENT THAT CANNOT BE INVESTIGATED WITHOUT EVALUATING SUBSTANTIALLY MORE INFORMATION, WHICH IS NOW ONLY AVAILABLE THROUGH THE LEGAL PROCESS APPLICABLE TO THIS CIVIL LAWSUIT. THE ALLEGATIONS WILL BE INVESTIGATED THROUGH DISCOVERY AND OTHER MEANS THAT MAY BECOME AVAILABLE AS THE LAWSUIT PROGRESSES. THE TENA PROTECTIVE UNDERWEAR PRODUCT LINE COMES IN VARIOUS SIZES. THE SPECIFIC SIZE ALLEGED TO HAVE BEEN WORN IS NOT REPORTED. THIS PRODUCT LINE COULD HAVE BEEN MANUFACTURED AT ONE OF THE SITES.

    Description of Event or Problem · 1

    MANUFACTURER RECEIVED SERVICE OF A COMPLAINT IN 2009, FOR A CIVIL ACTION IN WHICH MANUFACTURER, THE STATE OF DEPARTMENT OF SOCIAL AND HEALTH SERVICES, THE INDIVIDUAL OWNERS OF AN ADULT FAMILY HOME, AND AN EMPLOYEE OF THE ADULT FAMILY HOME WERE NAMED AS DEFENDANTS. PLAINTIFFS ALLEGE THAT WHILE ALONE AND UNSUPERVISED, AN ADULT MALE RESIDENT OF THE ADULT FAMILY HOME, DIED AFTER SUSTAINING SEVERE BURNS TO HIS BODY FROM A FIRE THAT BEGAN WHEN A DROPPED SPARK OR EMBER FROM A LIT CIGARETTE IGNITED THE JOGGING PANTS BEING WORN BY THE RESIDENT. PLAINTIFFS FURTHER ALLEGED THAT THE FLAMES FROM THE JOGGING PANTS WERE FANNED BY THE WIND, CAUSING THE FIRE TO SPREAD, EVENTUALLY BURNING OFF ALL OF THE RESIDENT'S CLOTHES, INCLUDING THE PROTECTIVE UNDERWEAR THAT THE RESIDENT WAS WEARING. THE RESIDENT'S CLOTHES, WHICH WERE MADE OF LIGHT WEIGHT SYNTHETIC FABRIC, AND THE PROTECTIVE UNDERWEAR ARE ALLEGED TO HAVE CONTRIBUTED TO THE INTENSITY OF THE FLAMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENA PROTECTIVE UNDERWEAR PROTECTIVE GARMENT FOR INCONTINENCE EYQ SCA PERSONAL CARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death