BEUDAMED
    FDA Adverse Event Other Summary report: N

    DALE STABILOCK ENDOTRACHEAL TUBE HOLDER

    MDR report key: 2768924 · Received September 27, 2012

    Report

    Report Number
    1214422-2012-00001
    Event Type
    Other
    Date Received
    September 27, 2012
    Date of Event
    August 20, 2012
    Report Date
    September 27, 2012
    Manufacturer
    DALE MEDICAL PRODUCTS, INC.
    Product Code
    CBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, DALE MEDICAL PERFORMED A COMPLETE HEALTH HAZARD ANALYSIS FOR OUR 270 DEVICE, THE DALE STABILOCK ET TUBE HOLDER SITED IN THIS REPORT. THE REPORT INCLUDED THAT DESPITE HAVING A DETECTABILITY RISK OF MODERATE BECAUSE THESE SKIN ISSUES ARE GENERALLY DETECTED UPON REMOVAL OF THE DEVICE, THE SEVERAL RISK LEVEL DETERMINATION FOR SKIN AND LIP IRRITATION/BREAKDOWN WAS DEEMED LOW AS ALL OF THE HAZARDS ARE MITIGATED BY THE STRONG WORDING ON DEVICE LABELING AS WELL AS THE DEVICE IFU. THIS CONCLUSION CAN BE BACKED UP BY THE FACT THAT DALE MEDICAL HAS SOLD (B)(4). (B)(4). ONE OF THE TWO REPORTED ISSUES NOTED ON THIS REPORT APPEARS TO BE AN ALLERGIC REACTION TO THE ADHESIVE BACKING ON THE DEVICE WHICH ALTHOUGH UNCOMMON, DOES HAPPEN WITH SOME PTS FOR ANY ADHESIVE TYPE PRODUCTS. THE OTHER ISSUES IS A PRESSURE SORE ON THE LIP WHICH IS GENERALLY CONSIDERED A TUBE ROTATION ISSUE.

    Description of Event or Problem · 1

    ON (B)(6) 2012, DALE MEDICAL PRODUCTS, INC. RECEIVED A CALL FROM A HEALTH CARE FACILITY IN (B)(6) TO REPORT THAT THEY HAD A PT THAT EXPERIENCED SKIN BREAKDOWN WHEN THE DALE MEDICAL 270 DEVICE, (ET TUBE HOLDER), WAS REMOVED FROM THE PT. ON (B)(6) 2012, REPRESENTATIVES OF DALE MEDICAL PRODUCTS, INC. CALLED THE FACILITY TO GAIN ADDITIONAL INFO AS FOLLOWS: DURING THE WEEK OF (B)(6) 2012, THE FACILITY WAS TRIALING THE DALE 270 DEVICE, AS THEY DO NOT USUALLY USE A COMMERCIALLY AVAILABLE ET TUBE HOLDER. THE FACILITY TRIALED THE DEVICE ON FOUR PTS AND TWO OF THE PTS DEVELOPED SKIN ISSUES; ONE PT EXHIBITED A DEEP PRESSURE SORE, APPROX 1.5CM BY 1.0CM ON THE LIP AND THE OTHER PT EXHIBITED SWOLLEN SKIN/EDEMA WITH SOME BREAKDOWN ON THE UPPER LIP, WHICH LOOKED TO THE CAREGIVER AS AN ALLERGIC REACTION.

    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 70 YR Other