BEUDAMED
    FDA Adverse Event Other Summary report: N

    DALE STABILOCK ENDOTRACHEAL TUBE HOLDER

    MDR report key: 2083116 · Received April 29, 2011

    Report

    Report Number
    1214422-2011-00006
    Event Type
    Other
    Date Received
    April 29, 2011
    Date of Event
    January 26, 2011
    Report Date
    April 29, 2011
    Manufacturer
    DALE MEDICAL PRODUCTS, INC.
    Product Code
    CBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DALE MEDICAL PRODUCTS INC. IS REPORTING THIS EVENT AT THE RECOMMENDATION OF AN FDA INVESTIGATOR DURING AN INSPECTION. THIS EVENT HAD ALREADY BEEN ENTERED INTO OUR CUSTOMER COMPLAINT DATABASE FOR INVESTIGATION. THE USER FACILITY REPORTED EXCORIATION ON THE UPPER LIP OF SOME PTS WHEN THE ADHESIVE PORTION OF THE DEVICE WAS REMOVED. AS NOTED, THIS TYPE OF ISSUE WAS NOT PREVIOUSLY REPORTED BY THIS USER FACILITY, BUT THAT PRACTICE HAS CHANGED OF LATE. THE ADHESIVE USED IN THIS DEVICE IS THE SAME AS THAT USED ON DALE DEVICE 160, NASOGASTRIC TUBE HOLDER AND WE HAVE NEVER HAD A REPORT OF SKIN ISSUES ASSOCIATED WITH THAT PRODUCT. (B)(4), WHERE THERE ARE SOME CASES OF SKIN BREAKDOWN.

    Description of Event or Problem · 1

    (NOTE: THIS EVENT IS BEING REPORTED NOW AS A RESULT OF AN FDA INSPECTION AT OUR FACILITY (DALE MEDICAL PRODUCTS, INC.) ON (B)(6) 2011. OUR INITIAL REVIEW OF THIS ISSUE CONCLUDED THAT THIS WAS NOT A REPORTABLE EVENT. HOWEVER, IT WAS THE OPINION OF THE INVESTIGATOR THAT THESE WERE REPORTABLE.) ON (B)(6) 2011, DALE MEDICAL RECEIVED A CALL FROM A HEALTHCARE FACILITY IN (B)(6) WHERE THEY SAID THAT THEY HAVE USED THE DALE 270 ET HOLDER CONSISTENTLY FOR 2 YEARS. THE USER FACILITY HAS EXPERIENCED EXCORIATION ON THE UPPER LIP, UNDER THE ADHESIVE PORTION OF THE DEVICE ON SOME PTS. IN THE PAST, THESE OCCURRENCES WERE NOT REPORTED, BUT DUE TO THE RECENT CHANGES IN THE (B)(6), THESE EVENTS MUST NOW BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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