BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIELLE HYDROPOLYMER ADHESIVE DRESSING

    MDR report key: 2007733 · Received February 25, 2011

    Report

    Report Number
    3007663067-2011-00001
    Event Type
    Injury
    Date Received
    February 25, 2011
    Report Date
    February 23, 2011
    Manufacturer
    SYSTAGENIX WOUND MANAGEMENT MANUFACTURING
    Product Code
    MGP
    PMA / PMN Number
    K983394
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA (B)(6) 2011. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE PT HAS A LEG ULCER SINCE (B)(6) OF 2010. IT HAS BEEN IN GRANULATION STAGE WITH NO EDEMA ASSOCIATED, SINCE (B)(6) 2010. SHE STARTED THE TREATMENT WITH THE DERMATOLOGIST IN (B)(6) AND IS NOW BEING TREATED WITH RAYON AGAIN. THE PAIN WAS TREATED WITH CELEBRA 100 MG (ANTI-INFLAMMATORY, ANALGESIC AND ANTIPYRETIC DRUG), CESACLOR 500 (ANTIBIOTIC) AND DEPROSONE (ANTI-INFLAMMATORY OINTMENT). SHE HAS BEEN USING DIPIRONA, PENTOXIFYLLINE 400 ML AND ALTARGO (ANTIBIOTIC OINTMENT) SINCE (B)(6).

    Description of Event or Problem · 1

    (B)(4), LOT NUMBER 0944112. CUSTOMER'S GRANDMOTHER WAS TREATING THE WOUND WITH RAYON (CELLULOSE ACETATE) AND THE DR INDICATED THE USE OF TIELLE. THE PT WAS 2 DAYS WITH THE DRESSING FEELING A LOT OF PAIN AND BLEEDING. THE BLEEDING THAT CUSTOMER DESCRIBES WAS EXUDATE MIXED WITH BLOOD, AND WITH RED COLOR SUCH AS BLOOD. NO MEDICAL INTERVENTION WAS REQUIRED TO STOP BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIELLE HYDROPOLYMER ADHESIVE DRESSING WOUND DRESSING MGP SYSTAGENIX WOUND MANAGEMENT MANUFACTURING 0944/1/1/2

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other