BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M TRANSPORE SURGICAL TAPE

    MDR report key: 3131017 · Received May 9, 2013

    Report

    Report Number
    2110898-2013-00023
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 22, 2013
    Manufacturer
    3M HEALTH CARE
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON JOURNAL ARTICLE - DID NOT INCLUDE INDIVIDUAL PATIENT SPECIFIC INFORMATION. BASED ON JOURNAL ARTICLE - DID NOT INCLUDE EVENT DATE. ADDITIONAL INFORMATION: THE ARTICLE REPORTS THAT ALTHOUGH THE SOURCE OF INFECTION WAS IDENTIFIED IN OUR CASE, THE PRECISE TIMING OF CONTAMINATION (DURING MANUFACTURING OR STORAGE) WAS NOT ESTABLISHED. METHOD: DEVICE NOT RECEIVED. CONCLUSIONS: DEVICE NOT PROVIDED TO MANUFACTURER FOR EVALUATION. COMPLAINT TYPE IS BEING MONITORED AND ANALYZED. THE INVESTIGATION OF THIS INCIDENT IS COMPLICATED BY HOW LONG AGO IT HAPPENED. IF ADDITIONAL INFORMATION IS OBTAINABLE, WE WILL FILE A SUPPLEMENT. NO OTHER COMPLAINTS OF THIS TYPE FOR TRANSPORE TAPE HAVE BEEN REPORTED TO 3M.

    Description of Event or Problem · 1

    THIS REPORTED EVENT DISCOVERED IN A PUBLICATION. THE JOURNAL OF HOSPITAL INFECTION, 81 (2012) 213-215, ALLEGED INFECTIONS ASSOCIATED WITH TRANSPORE SURGICAL TAPE. THE ARTICLE REPORTED CUTANEOUS ZYGOMYCOSIS OCCURRED IN FOUR PATIENTS, TWO MALE AND TWO FEMALE AGED 15-88. THE ARTICLE REPORTED ALL AFFECTED PATIENTS WERE NEUTROPENIC, THREE FOLLOWING CHEMOTHERAPY FOR ACUTE MYELOID LEUKAEMIA (AML) ACUTE LYMPHOBLASTIC LEUKAEMIA (ALL) AND NON-HODKIN LYMPHOMA (NHL) AND ONE DUE TO VERY SEVERE APLASTIC ANAEMIA (AVAA). THE ARTICLE REPORTED PATIENTS PRESENTED WITH ITCHY ERYTHEMA, UNDER POLYETHYLENE TAPE USED TO STABILIZE A PERIPHERAL VENOUS CATHETER IN THE USED TO STABILIZE A PERIPHERAL VENOUS CATHETER IN THE PATIENTS' FOREARM (SURGICAL TAPE, TRANSPORE). THE ARTICLE REPORTED OVER THE NEXT 48-72 HOURS THE AREA PROGRESSED TO ULCERATION WITH NECROSIS DEFINED BY A SHARP BORDER OR TO THE DEVELOPMENT OF AN EXOPHYTIC NECROTIC TISSUE. ARTICLE REPORTED PATIENTS ALSO EXPERIENCED FEVER, LOCAL EDEMA AND PAIN. ARTICLE REPORTED MRI IMAGING PERFORMED IN TWO PATIENTS REVEALED INFILTRATION OF UNDERLYING TISSUES (MUSCLES AND FASCIA) AND SURGICAL DEBRIDEMENT WAS REQUIRED IN THREE OF FOUR PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204922 3M TRANSPORE SURGICAL TAPE TAPE AND BANDAGE, ADHESIVE KGX 3M HEALTH CARE NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other