BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DALE STABILOCK ENDOTRACHEAL TUBE HOLDER

    MDR report key: 3010926 · Received March 18, 2013

    Report

    Report Number
    1214422-2013-00001
    Event Type
    Injury
    Date Received
    March 18, 2013
    Date of Event
    February 4, 2013
    Report Date
    March 12, 2013
    Manufacturer
    DALE MEDICAL PRODUCTS, INC.
    Product Code
    CBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WHO CALLED WAS THE RESPIRATORY MANAGER, AND RELAYED INFORMATION THAT SHE HAD RECEIVED AS THE EVENT TOOK PLACE ON THE WEEKEND SHIFT AT THE HOSPITAL. DALE ANSWERED THE INITIAL QUESTION OF HAD ANYTHING IN OUR PRODUCT CHANGED RECENTLY WITH THE RESPONSE NO, THERE HAVE BEEN NO RECENT CHANGES TO THE PRODUCT. THE FOLLOWING QUESTIONS WERE ASKED BY DALE AND ANSWERED BY THE CUSTOMER: BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER AND THE TESTING ON PIECES FROM THE SAME LOT OF DEVICES, DALE MEDICAL PRODUCTS, INC. HAS CONCLUDED THAT THERE ARE NO ISSUES WITH THE DEVICES AND THE CAUSE OF THE SKIN ISSUES IS MOST LIKELY PATIENT SPECIFIC; SUCH AS AN ALLERGY, MEDICAL CONDITION OR SKIN CONDITION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A CUSTOMER CALLED FROM (B)(6) HOSPITAL TO REPORT THAT THEY HAD FOUR PATIENTS THAT EXPERIENCED SKIN TEARS ON THEIR UPPER LIP WHEN THE DALE 273 FACE PLATE WAS REMOVED FOR REPLACEMENT. THE CUSTOMER WANTED TO INQUIRE IF DALE HAD MADE ANY CHANGES TO THE 270 / 273 DEVICE AS THEY HAVE BEEN USING THE DEVICE SUCCESSFULLY FOR SEVERAL YEARS AT THEIR FACILITY. THE CUSTOMER PROVIDED US WITH LOT # 12-04-12 FOR THE 270 DEVICE AND (B)(4) FOR THE ENCLOSED 273 DEVICES, BOTH OF WHICH APPEAR TO HAVE BEEN USED ON ALL FOUR PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112203 DALE STABILOCK ENDOTRACHEAL TUBE HOLDER REG 868.5770 CBH DALE MEDICAL PRODUCTS, INC. 270 12-04-12

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other