BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M TRANSPORE WHITE SURGICAL TAPE

    MDR report key: 2132554 · Received June 9, 2011

    Report

    Report Number
    2110898-2011-00071
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 12, 2011
    Manufacturer
    3M HEALTH CARE
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: TESTING NOT PERFORMED. RESULTS: PRODUCT NOT RETURNED. CONCLUSIONS: NO EVAL WILL BE PERFORMED. COMMON TAPE APPLICATION TECHNIQUE: ALWAYS APPLY TAPE ON SKIN THAT IS DRY, CLEAN AND FREE FROM SOAPS, CHEMICALS AND OILS. IF NEEDED, APPLY A SKIN PROTECTOR AND ALLOW IT TO DRY BEFORE USING TAPE. AVOID USING TINCTURE OF BENZOIN, AS IT CAN BE A SKIN IRRITANT. APPLY TAPE WITHOUT TENSION AND SMOOTH FROM THE CENTER OUT. ALLOW AT LEAST 1" OF TAPE AROUND DRESSING EDGES. DO NOT SECURE ONE END OF THE TAPE AND APPLY TENSION WHILE SECURING THE OTHER END OF THE TAPE. THIS MAY INDUCE SKIN TRAUMA IN BLISTERING OR SKIN TEARING. MAXIMIZE ADHESION BY FIRMLY PRESSING OR RUBBING THE TAPE INTO PLACE ON SKIN, TUBING OR APPLIANCES. COMMON TAPE REMOVAL TECHNIQUE: LOOSEN ALL ENDS OF THE TAPE STRIPS, OR EDGES OF DRESSINGS. GRASP THE FULL WIDTH OF THE TAPE AND SLOWLY AND GENTLY PULL THE TAPE BACK OVER ITSELF TOWARD THE WOUND TO MINIMIZE DISRUPTION OF HEALING TISSUE. TAPE SHOULD BE REMOVED IN THE DIRECTION OF HAIR GROWTH WHENEVER POSSIBLE, IF THIS WILL NOT DISTURB THE WOUND AREA. KEEP THE TAPE CLOSE TO THE SKIN SURFACE AS YOU PULL IT BACK, AND SUPPORT THE SKIN IMMEDIATELY ADJACENT TO THE STRIP BEING REMOVED.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT THEY APPLIED TRANSPORE TO SECURE NEEDLES DURING DIALYSIS. THE CUSTOMER STATES THAT THE PT WAS ASLEEP AND NO ONE SAW WHAT HAD HAPPENED, BUT BLOOD WAS SEEN ON THE FLOOR AND THE CUSTOMER NOTED THAT THE VENOUS NEEDLE HAD DISLODGED FROM THE PT. THE PT COMPLAINED OF DIZZINESS. PT WAS TAKEN TO A HOSP AND RECEIVED A BLOOD TRANSFUSION. NURSE STATED THAT THE PT STAYED OVERNIGHT AT THE HOSP AND IS BACK AT THE FACILITY RECEIVING ROUTINE DIALYSIS. NURSE ALSO STATED THAT THIS WAS AN ISOLATED INCIDENT AND THEY WERE NOT ABLE TO DETERMINE THE EXACT CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M TRANSPORE WHITE SURGICAL TAPE 880.5240 MEDICAL ADHESIVE TAPE & BANDAGE KGX 3M HEALTH CARE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization