BEUDAMED
    FDA Adverse Event Other Summary report: N

    DALE STABILOCK ENDOTRACHEAL TUBE HOLDER

    MDR report key: 2083103 · Received April 29, 2011

    Report

    Report Number
    1214422-2011-00003
    Event Type
    Other
    Date Received
    April 29, 2011
    Date of Event
    December 1, 2009
    Report Date
    April 29, 2011
    Manufacturer
    DALE MEDICAL PRODUCTS, INC.
    Product Code
    CBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TO RE-ITERATE: 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. ADDITIONALLY, (B)(4), WHERE THE FACILITY WAS LOOKING FOR ADDITIONAL INFORMATION OR IN-SERVICE TRAINING.

    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.) IN (B)(4) 2009, DALE MEDICAL ATTENDED THE (B)(6) CONFERENCE WHICH WE NORMALLY DO. AT THE CONFERENCE, IT WAS REPORTED BY A HEALTHCARE FACILITY IN TEXAS THAT THEY HAD SEEN PT SKIN BREAKDOWN WITH THE DALE MEDICAL 270 DEVICE. AFTER THE CONFERENCE, DALE MEDICAL PERSONNEL CONTACTED THE USER FACILITY FOR ADDITIONAL DETAILS ON THE SKIN BREAKDOWN. THE FACILITY REPLIED THAT THERE HAD BEEN SEVERAL PTS WITH BREAKDOWN ON THE LIP(S). THEY ALSO INDICATED THAT RESPIRATORY DOES NOT TRACK SKIN BREAKDOWN ROUTINELY, NOR BRADEN SCORES, THEREFORE, PT SPECIFIC DATA WAS NOT AVAILABLE FOR REVIEW OR DISCUSSION.

    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