BEUDAMED
    FDA Adverse Event Death Summary report: N

    DALE

    MDR report key: 68771 · Received February 14, 1997

    Report

    Report Number
    1214422-1997-90001
    Event Type
    Death
    Date Received
    February 14, 1997
    Date of Event
    January 16, 1994
    Report Date
    February 14, 1997
    Manufacturer
    DALE MEDICAL PRODUCTS, INC.
    Product Code
    BTO
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS TO NOTIFY THAT CONTROL NUMBER 19120 FILED WITH THE OFFICE IN 02/1997 IS COMPLETE. CO HAS REC'D NOTIFICATION THAT DALE MEDICAL PRODUCTS, INC. WAS NOT LIABLE IN THE CASE AGAINST THE USER.

    Description of Event or Problem · 1

    THIS REPORT, RECEIVED ON 2/12/97 DOCUMENTS AN INCIDENT THAT TOOK PLACE ON 1/16/95. MUCH TESTIMONY WILL HAVE TO TAKE PLACE TO RESOLVE THE ALLEGATIONS IN THE REPORT, BUT CO'S INITIAL REACTION IS THAT THE TRACHEOSTOMY TUBE HOLDER, COULD NOT HAVE BEEN A CAUSE OF DEATH BECAUSE THE INFANT INVOLVED WAS NOT ON A VENTILATOR, AND WOULD HAVE BEEN ABLE TO BREATHE EVEN IF A TRACHEAL TUBE BECAME DISLODGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DALE TRACHEOSTOMY TUBE HOLDER BTO DALE MEDICAL PRODUCTS, INC. 240 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *