BEUDAMED
    FDA Adverse Event Injury Summary report: N

    270 STABILOCK ET HOLDER

    MDR report key: 14013282 · Received April 5, 2022

    Report

    Report Number
    1214422-2022-00005
    Event Type
    Injury
    Date Received
    April 5, 2022
    Date of Event
    February 10, 2022
    Report Date
    April 4, 2022
    Manufacturer
    DALE MEDICAL PRODUCTS, INC.
    Product Code
    CBH
    UDI-DI
    00817612020506
    PMA / PMN Number
    LISTING ONLY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT BEING TREATED USING THE DALE 270 ET TUBE HOLDER DEVELOPED A SEVERE FACIAL WOUND UNDER THE DALE ET HOLDER DEVICE. DALE MEDICAL HAS INVESTIGATED THE REPORT INCLUDING INSPECTION AND TESTING OF A DEVICE FROM THE SAME LOT NUMBER 27608 AS THE ONE REPORTED WITH NO ISSUES NOTED. A COMPLETE REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS PRODUCTION LOT ALSO FOUND NO ISSUES. DALE MEDICAL ALSO PERFORMED INSPECTION AND TESTING AND DHR REVIEW ON OTHER PRODUCTION LOT'S THAT WERE PRODUCED IN THE SAME TIMEFRAME WITH NO ISSUES NOTED. DALE MEDICAL HAS REVIEWED OUR CUSTOMER COMPLAINT FILES AND NOTED THAT WE HAD NO OTHER COMPLAINTS AGAINST THE DALE 270 DEVICE IN THE LAST THREE YEARS; 2019-2021, (B)(4). THE DALE 270 DEVICE PACKAGING FOR THE ADHESIVE BASE THAT IS APPLIED TO THE PATIENT'S SKIN CONTAINS THIS WORDING: APPLY SKIN PREP. LET DRY TO PREVENT SKIN ULCERATIONS OR SKIN TEARS, ASSESS PATIENT SKIN AND MEDICAL CONDITIONS PRIOR TO APPLYING. MONITOR DAILY OR MORE FREQUENTLY. WE HAVE FOUND THROUGH MANY YEARS OF EXPERIENCE WITH OUR 270 DEVICE THAT WHEN ALL PROVISIONS OF OUR INSTRUCTIONS FOR USE ARE FOLLOWED, INCLUDING USING THE SUPPLIED SKIN PREP (BARRIER WIPE), THERE ARE VERY FEW ISSUES REPORTED. DALE MEDICAL THEREFORE HAS CONCLUDED THAT THERE APPEARS TO BE NO ISSUES WITH THE DEVICE AND THE CAUSE OF THE FACIAL WOUND COULD BE RELATED TO NOT USING THE SUPPLIED SKIN PREP (BARRIER WIPE), AS THE REPORTING FACILITY HAD NO RECORD OF THE SKIN PREP BEING USED.

    Description of Event or Problem · 0

    "PATIENT DEVELOPED SEVERE FACIAL WOUND UNDER DALE ET HOLDER DEVICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77704 270 STABILOCK ET HOLDER 270 STABILOCK ET HOLDER CBH DALE MEDICAL PRODUCTS, INC. 270 27608 00817612020506

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Other