BEUDAMED
    FDA Adverse Event Other Summary report: N

    3M STERI-STRIP COMPOUND BENZOIN TINCTURE

    MDR report key: 2494121 · Received March 7, 2012

    Report

    Report Number
    2110898-2012-00008
    Event Type
    Other
    Date Received
    March 7, 2012
    Date of Event
    February 6, 2012
    Report Date
    February 6, 2012
    Manufacturer
    3M HEALTH CARE
    Product Code
    FQM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WET PRUF TAPE IS NOT A 3M PRODUCT. FACILITY RETURNED TO USING MASTISOL AND IS NOT HAVING ANY FURTHER PROBLEMS. CONCLUSIONS: DEVICE NOT RETURNED NO EVAL CAN BE PERFORMED. DEVICE NOT PROVIDED TO MANUFACTURER FOR EVAL.

    Description of Event or Problem · 1

    PICU NURSE MANAGER ALLEGES SEVERAL WEEKS AGO WHEN THEY BEGAN USE OF TINCTURE BENZOIN UNDER WET PRUF TAPE USED TO SECURE ET TUBES, THERE WERE FOUR EXTUBATIONS. STATES THREE PTS WERE RE-INTUBATED, AND ONE DID NOT NEED TO BE RE-INTUBATED. STATED SHE IS NOT SURE IF USE OF TINCTURE BENZOIN WAS THE FACTOR THAT LED TO THESE OCCURRENCES. STATES INFANTS WERE UNDER THE AGE OF SIX MONTHS. NURSE MANAGER UNABLE TO PROVIDE SPECIFIC DETAILS ON EACH INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M STERI-STRIP COMPOUND BENZOIN TINCTURE SEC. 880.5240 MEDICAL ADHESIVE TAPE. FQM 3M HEALTH CARE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention WET-PRUF TAPE