BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOLIFE BIOGLUE SURGICAL ADHESIVE

    MDR report key: 2222038 · Received August 18, 2011

    Report

    Report Number
    MW5021824
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Date of Event
    June 14, 2011
    Report Date
    August 18, 2011
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MFI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE OF TWO EVENTS: (B)(6) 2011. PT HAD BEEN CULTURED FOR COAGULASE-NEGATIVE (B)(6). THE PT HAD PREVIOUSLY BEEN THOUGHT TO HAVE A SUTURE GRANULOMA. THE DISSECTION TOOK SURGEON DOWN TO A LARGE RETAINED BLOCK OF BIOGLUE. THIS WAS TROUBLING AS BIOGLUE HAS BEEN PROMOTED AS A SUBSTANCE THAT WILL BE REABSORBED OVER THE COURSE OF SEVERAL MONTHS. OBVIOUSLY IT DID NOT TAKE PLACE IN THIS CASE AND WAS THE SOURCE OF THE GRANULOMA. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOLIFE BIOGLUE SURGICAL ADHESIVE BIOGLUE MFI CRYOLIFE, INC. PO10003

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other