BEUDAMED
    FDA Adverse Event Other Summary report: N

    DALE STABILOCK ENDOTRACHEAL TUBE HOLDER

    MDR report key: 2083104 · Received April 29, 2011

    Report

    Report Number
    1214422-2011-00004
    Event Type
    Other
    Date Received
    April 29, 2011
    Date of Event
    July 7, 2010
    Report Date
    April 29, 2011
    Manufacturer
    DALE MEDICAL PRODUCTS, INC.
    Product Code
    CBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 REQUEST FOR ADDITIONAL IN-SERVICING", REGARDING THE PROPER USE OF THE DALE 270 DEVICE. THE USER FACILITY HAD NOTICED SOME ULCERATIONS ON PTS UPPER LIPS. DURING THE REQUESTED IN-SERVICE TRAINING, IT WAS FOUND THAT THE USER FACILITY WAS NOT ALWAYS FOLLOWING THE RECOMMENDATIONS ON THE PRODUCT LABELING, SPECIFICALLY, NOT REPOSITIONING THE ET TUBE OFTEN TO HELP PREVENT INJURY TO THE LIPS. (B)(4), WHERE THE FACILITY WAS LOOKING FOR ADDITIONAL INFORMATION ON 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.) ON (B)(6) 2010, DALE MEDICAL RECEIVED A CALL FROM A HEALTHCARE FACILITY IN (B)(6), WHERE THEY STATED THAT THEY HAVE HAD SOME ULCERATIONS ON PTS' UPPER LIPS FROM THE DALE 270 DEVICE AND REQUESTED ADDITIONAL IN-SERVICE TRAINING FOR THE RESPIRATORY STAFF THERE. THE USER FACILITY REPRESENTATIVE INDICATED THAT SHE THOUGHT THE NURSES WERE PINCHING THE LIP WHEN APPLYING THE DALE 270 DEVICE. ON (B)(6) 2010, DALE MEDICAL PERSONNEL WENT TO THE USER FACILITY AND PROVIDED THE ADDITIONAL IN-SERVICE TRAINING THAT WAS REQUESTED. DURING THE VISIT, DALE PERSONNEL WERE TOLD THAT THE ET TUBE WAS NOT BEING REPOSITIONED AS RECOMMENDED BY DALE MEDICAL ON THE DEVICE LABELING.

    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