BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPLUS C VIOLET 0 (3,5) 25M

    MDR report key: 3821379 · Received January 14, 2014

    Report

    Report Number
    2916714-2014-00015
    Event Type
    Malfunction
    Date Received
    January 14, 2014
    Date of Event
    November 29, 2013
    Report Date
    January 10, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US 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). SUTURE BRITTLE AND BREAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37297 MONOPLUS C VIOLET 0 (3,5) 25M NONE GAM B. BRAUN SURGICAL S.A. F0024273 112183

    Patients

    Seq Age Sex Outcome Treatment
    1 Other