BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL BLUE 0.5 ML

    MDR report key: 3821501 · Received January 15, 2014

    Report

    Report Number
    2916714-2014-00040
    Event Type
    Malfunction
    Date Received
    January 15, 2014
    Report Date
    January 15, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    MPN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2013. REPORTED DEVICE NOT MARKETED IN THE US; HOWEVER, SIMILAR DEVICE IS. EVALUATION ON-GOING AT MANUFACTURING SITE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). INCISION CRACKED AFTER USE OF HISTOACRYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40849 HISTOACRYL BLUE 0.5 ML NONE MPN B. BRAUN SURGICAL S.A. 1050044 213242N2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other