BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M CLOTH ADHESIVE TAPE (LATEX FREE)

    MDR report key: 4645766 · Received February 12, 2015

    Report

    Report Number
    2110898-2015-00005
    Event Type
    Injury
    Date Received
    February 12, 2015
    Date of Event
    January 1, 2015
    Report Date
    February 4, 2015
    Manufacturer
    3M DEUTSCHLAND GMBH, HEALTH CARE BUISNESS
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT REC'D. RESULTS: NO EVAL PERFORMED. CONCLUSIONS: DEVICE NOT RETURNED NO EVAL CAN BE PERFORMED. COMPLAINT TYPE IS BEING MONITORED AND ANALYZED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED 2950-1 CLOTH ADHESIVE TAPE IS USED FOR SECUREMENT OF ENDOTRACHEAL TUBES IN THE NICU. ALLEGED 3 PTS EXPERIENCED ACCIDENTAL ENDOTRACHEAL TUBE EXTUBATION BECAUSE TAPE DID NOT ADHERE WELL TO INFANT'S SKIN. REPORTED ALL 3 PTS WERE RE-INTUBATED AND NO OTHER ADD'L MEDICAL TREATMENT WAS REQUIRED. NO INDIVIDUAL SPECIFIC PT INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105882 3M CLOTH ADHESIVE TAPE (LATEX FREE) TAPE AND BANDAGE, ADHESIVE KGX 3M DEUTSCHLAND GMBH, HEALTH CARE BUISNESS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention