BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIGIS ANTIBACTERIAL ENVELOPE

    MDR report key: 3250525 · Received June 26, 2013

    Report

    Report Number
    MW5031069
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    TYRX
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVELOPED HYPOTENSION AND RASH FOLLOWING IMPLANTATION OF SUBMUSCULAR TYRX AIGIS (ALLERGIC REACTION) RESOLVED FOLLOWING DEVICE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289532 AIGIS ANTIBACTERIAL ENVELOPE 3IN X 6IN AIGIS RX ICD CUSTOM FTL TYRX

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization PROTONIX 40MG QD PO| METOPROLOL XL 100MG PO QD| ENDOTAK RELIANCE SG59 CM, MODEL 0292, SN (B)(4)| ACUITY SPIRAL, MODEL 4592-90CM, (B)(4)| LOPID 600 MG PO BIO| GUIDANT, MODEL 4469 45 CM, SN (B)(4)| CLINDAMYCIN 300MG PO Q12H| DAPTOMYCIN & SODIUM CHLORIDE 600MG IVPB Q24H| DEPAKOTE EC 250MG PO Q12H| BOSTON SCIENTIFIC INCEPTA CRT-D, MODEL NI60,| LISINOPRIL 5MG PO QD| SN (B)(4)| LASIX 20MG PO QD