BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TSL

    MDR report key: 2002335 · Received February 14, 2011

    Report

    Report Number
    9617613-2011-00002
    Event Type
    Injury
    Date Received
    February 14, 2011
    Date of Event
    September 11, 2009
    Report Date
    January 14, 2011
    Manufacturer
    TISSUE SCIENCE LABORATORIES
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HERNIA. ACCORDING TO THE REPORTER: APPROXIMATELY 8 MONTHS POST-OPERATIVELY, THE PATIENT BEGAN TO SHOW SIGNS OF RED DOTS ON ABDOMEN, ALLEGEDLY, ATOPIC DERMATITIS WHICH SPREAD TO OTHER PARTS OF THE PATIENT'S BODY. PATIENT IS TAKING MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN TSL TSL FTL TISSUE SCIENCE LABORATORIES UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other