BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHILON NYLON SUTURE

    MDR report key: 2896877 · Received January 4, 2013

    Report

    Report Number
    2210968-2013-00111
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    October 19, 2012
    Report Date
    December 12, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    GAO
    PMA / PMN Number
    N85316
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. THIS IS ONE OF SIX MEDWATCHES BEING SUBMITTED AS SIX DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCHES 2210968-2013-00110 THROUGH 2210968-2013-00115.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS NOTED BY THE HOSPITAL STAFF THAT WHEN THE PACKAGE WAS OPENED THE SUTURE APPEARED TO BE STICKING TO THE PACKAGE AND THE LABEL WAS MELTED. THIS OCCURRED PRIOR TO USE ON A PATIENT. THEREFORE THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4954 ETHILON NYLON SUTURE SUTURE, NON-ABSORBABLE GAO ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1