BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUROLON NYLON SUTURE

    MDR report key: 1892867 · Received November 3, 2010

    Report

    Report Number
    2210968-2010-01426
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    September 9, 2010
    Report Date
    October 6, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAR
    PMA / PMN Number
    N85316
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A NEUROSURGICAL PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AT THE JUNCTURE OF THE NEEDLE AND THE SUTURE. ALL NEEDLE PIECES WERE ACCOUNTED FOR AND THERE WERE NO ADVERSE PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUROLON NYLON SUTURE SUTURE, NON-ABSORBABLE GAR ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR