BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DALE STABILOCK ENDOTRACHEAL TUBE HOLDER

    MDR report key: 3496377 · Received November 20, 2013

    Report

    Report Number
    1214422-2013-00002
    Event Type
    Injury
    Date Received
    November 20, 2013
    Date of Event
    November 1, 2013
    Report Date
    November 15, 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

    ON (B)(4) 2013, A DALE MEDICAL SALES REP, VISITED THE NOTED FACILITY MEETING WITH THE RT DIRECTOR, CLINICAL COORDINATOR AND MEMBERS OF THE RT STAFF FROM THE DAY SHIFT AND NIGHT SHIFT. IN CONVERSATION IT WAS NOTED THAT THE ISSUES WERE ALL IN THE ICU ON VARIOUS (UP TO 5) PTS. ALL THE PTS WERE IN POOR HEALTH WITH SOME PRE-CONDITIONS AND ON VARIOUS MED'S. IT WAS STATED THAT THE PTS EXHIBITED BROKEN SKIN, BUT NO BLEEDING OR BLOOD, JUST A RED AREA WHEN THE ADHESIVE BASE WAS REMOVED AFTER 3 DAYS. THE FOLLOWING GENERAL QUESTIONS WERE ASKED BY DALE AND ANSWERED BY THE CUSTOMER: THE DALE SALES REP PROVIDED IN-SERVICING TO ALL THE RT TECHNICIANS ON THE DAY AND THE NIGHT SHIFT DURING THE VISIT. THE IFU VIDEO FROM THE DALE WEBSITE WAS REVIEWED BY THE STAFF AND THE RT DIRECTOR DOWNLOADED THE VIDEO FOR FUTURE USE FOR STAFF TRAINING. BASED ON THE INFO PROVIDED BY THE CUSTOMER CONTACTS, DALE MEDICAL PRODUCTS, INC. HAS CONCLUDED THAT THERE ARE NO ISSUES WITH THE DEVICES AND THE CAUSE OF THE SKIN ISSUES IS MOST LIKELY A DEVICE APPLICATION ISSUE OR PT SPECIFIC; SUCH AS AN ALLERGY, MEDICAL CONDITION OR SKIN CONDITION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE RT DIRECTOR FOR THE FACILITY REPORTED THAT THEY WERE HAVING SKIN BREAKDOWN ISSUES WITH THE DALE 270 DEVICE AND REQUESTED THAT A DALE REP VISIT THEM ON MONDAY, (B)(4) 2013 TO REVIEW THE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601146 DALE STABILOCK ENDOTRACHEAL TUBE HOLDER PRODUCT CODE CBH, REG 868.5770 CBH DALE MEDICAL PRODUCTS, INC. 270

    Patients

    Seq Age Sex Outcome Treatment
    1 Other