BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPLUS C VIOLET 0 (3, 5) 25M

    MDR report key: 3982734 · Received June 16, 2014

    Report

    Report Number
    2916716-2014-00451
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    April 10, 2014
    Report Date
    June 14, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAM
    PMA / PMN Number
    K030216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MFG SITE EVAL: EVAL ON GOING AT MFG SITE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THREAD BREAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353321 MONOPLUS C VIOLET 0 (3, 5) 25M SYNTHETIC ABSORBABLE SUTURE GAM B. BRAUN SURGICAL S.A. F0024273 113174

    Patients

    Seq Age Sex Outcome Treatment
    1 Other