BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOMAX VIOLET 1 (4) 90CM HR48 (M)

    MDR report key: 3829802 · Received May 6, 2014

    Report

    Report Number
    2916714-2014-00333
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 6, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    NWJ
    PMA / PMN Number
    K100876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFG SITE EVAL: EVAL IS ON-GOING.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THE INNER POUCH STICKS TO THE OUTER POUCH. IT IS HARD TO GET IT OUT AND OFTEN THE SCRUB NURSES ARE GETTING CONTAMINATED AND HAVE TO CHANGE GLOVES AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270237 MONOMAX VIOLET 1 (4) 90CM HR48 (M) SYNTHETIC ABSORBABLE SUTURE NWJ B. BRAUN SURGICAL S.A. B0041138 114053

    Patients

    Seq Age Sex Outcome Treatment
    1 Other