BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN QUICK UND 3/0 (2) 45CM DSMP24 (M)

    MDR report key: 3982590 · Received June 16, 2014

    Report

    Report Number
    2916714-2014-00463
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 14, 2014
    Report Date
    June 16, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAM
    PMA / PMN Number
    K011375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. EVAL IN PROGRESS.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THE THREAD CAUSED ERYTHRODERMIA (INFLAMMATION WITH SCALING) AND ITCH. THIS HAPPENED BY SEVERAL PTS. MONOSYN QUICK IS USED FOR SUBCUTICULAR SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353527 MONOSYN QUICK UND 3/0 (2) 45CM DSMP24 (M) SUTURE GAM B. BRAUN SURGICAL S.A. C0025040 113174V004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other