BEUDAMED
    FDA Adverse Event Other Summary report: N

    DALE STABILOCK ENDOTRACHEAL TUBE HOLDER

    MDR report key: 2083114 · Received April 29, 2011

    Report

    Report Number
    1214422-2011-00002
    Event Type
    Other
    Date Received
    April 29, 2011
    Date of Event
    December 21, 2009
    Report Date
    April 29, 2011
    Manufacturer
    DALE MEDICAL PRODUCTS, INC.
    Product Code
    CBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TO RE-ITERATE THE NOTE; DALE MEDICAL PRODUCTS, INC. IS REPORTING THIS EVENT AT THE RECOMMENDATION OF AN FDA INVESTIGATOR DURING AN INSPECTION. THIS EVENT WAS ORIGINALLY ENTERED INTO OUR COMPLAINT DATABASE AS A "CUSTOMER INQUIRY" REGARDING THE PROPER USE OF THE DALE 270 DEVICE. THE FACILITY HAD NOTICED SOME LIP TEARS ON PTS WHEN THE ADHESIVE PORTION OF THE DEVICE WAS REMOVED. SOME OF THE RECOMMENDATIONS ON THE DEVICE LABELING WERE NOT FOLLOWED SUCH AS CONSISTENT USE OF A BARRIER WIPE, SUPPORTING OF THE VENTILATOR ARM, AND ASSESSING THE PTS SKIN CONDITION PRIOR TO USE. 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).

    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)(4) 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)(4) 2009, DALE MEDICAL RECEIVED A CALL FROM A HEALTH CENTER IN (B)(6), REPORTING THAT THEY HAD 2 OF 3 PTS THAT EXPERIENCED SKIN TEARS WHEN THE DALE MEDICAL 270 DEVICE, ADHESIVE PORTION, (ET TUBE HOLDER) WAS REMOVED FROM THE PTS, AND THEY WANTED ADDITIONAL INFORMATION ON USING THE DEVICE CORRECTLY. DALE MEDICAL PERSONNEL ASKED A SERIES OF STANDARD QUESTIONS FOR THIS DEVICE WITH THE FOLLOWING RESPONSE, THE USER FACILITY CAN NOT GUARANTEE THAT A BARRIER WIPE, WHICH IS INCLUDED WITH THE PRODUCT, WAS USED ON THE PTS. THE USER FACILITY DOES NOT USE A DEVICE TO SUPPORT THE VENTILATOR TUBING WHICH IS STRONGLY RECOMMENDED ON THE 270 DEVICE PACKAGING. THE PTS WERE OVER 75 YEARS WITH DEBILITATING ILLNESS.

    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 75 YR Other