BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DALE 242 BLUE TRACHEOSTOMY TUBE HOLDER

    MDR report key: 938077 · Received April 16, 2007

    Report

    Report Number
    1214422-2007-00003
    Event Type
    Malfunction
    Date Received
    April 16, 2007
    Date of Event
    March 31, 2007
    Report Date
    April 13, 2007
    Manufacturer
    DALE MEDICAL PRODUCTS, INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF THE USED PRODUCT, IT WAS NOTED THAT A SMALL PIECE OF THE LONG FASTENER TAB HAD BEEN CUT TOO CLOSE TO THE STITCHING OF THE HOOK. THIS TYPE OF ALTERATION BY THE CUSTOMER WOULD CAUSE THE PERFORMANCE OF THE PRODUCT TO BE JEOPARDIZED.

    Description of Event or Problem · 1

    PT DECANNULATED WHILE WEARING THE DALE TRACHEOSTOMY TUBE HOLDER. THE TRACHEOSTOMY TUBE WAS REINSERTED WITH GOOD OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DALE 242 BLUE TRACHEOSTOMY TUBE HOLDER TRACHEOSTOMY TUBE HOLDER BTO DALE MEDICAL PRODUCTS, INC. 242 *

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Other| R