BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFT VASC 30CM X 24MM HMSH PL AND 30CM X 8MM HMSH G

    MDR report key: 11560583 · Received March 23, 2021

    Report

    Report Number
    MW5100205
    Event Type
    Injury
    Date Received
    March 23, 2021
    Date of Event
    December 9, 2020
    Report Date
    March 19, 2021
    Manufacturer
    GETINGE US SALES, LLC
    Product Code
    MAL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD IMPLANTS FOR EMERGENT SURGERY ON (B)(6) 2020, INFORMED BY (B)(6) MEDICAL CENTER ON (B)(6) 2020 THAT THERE WAS A CONCERN REGARDING FUNGAL INFECTION LATER DETERMINED TO BE A POSSIBLE ASPERGILLUS UDAGAWAE SURGICAL SITE INFECTION THAT MAY OR MAY NOT BE ATTRIBUTED TO THE IMPLANTED GRAFT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445514 GRAFT VASC 30CM X 24MM HMSH PL AND 30CM X 8MM HMSH G GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE MAL GETINGE US SALES, LLC M00202175424PO 19J18
    445515 GRAFT VASC 30CM X 24MM HMSH PL AND 30CM X 8MM HMSH G GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE MAL GETINGE US SALES, LLC M002020954080 20E06

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization