BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFIL VIOLET 4/0 (1.5) 70CM HR17 (M)

    MDR report key: 3757413 · Received January 3, 2014

    Report

    Report Number
    2916714-2014-00008
    Event Type
    Malfunction
    Date Received
    January 3, 2014
    Report Date
    January 3, 2014
    Manufacturer
    B BRAUN SURGICAL S.A.
    Product Code
    GAM
    PMA / PMN Number
    K031286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: ONE UNOPENED BOX WITH WRONG PRE-PRINTED BOX. NOVOSYN INSTEAD OF SAFIL. BOX LABEL AND PRODUCT INSIDE ARE CORRECT: SAFIL (B)(4) BATCH 113401. RESULTS ARE NOT COMPLETE AT THIS TIME; EVAL ON-GOING AT MFG SITE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). INCORRECT PACKAGING (OUTER BOX).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3720 SAFIL VIOLET 4/0 (1.5) 70CM HR17 (M) GAM B BRAUN SURGICAL S.A. C1048013 113401

    Patients

    Seq Age Sex Outcome Treatment
    1 Other