BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHILON NYLON SUTURE

    MDR report key: 1812728 · Received August 13, 2010

    Report

    Report Number
    2210968-2010-00922
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 15, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAR
    PMA / PMN Number
    N85316
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AT THE SWAGE. NO FRAGMENT REMAINED IN THE PATIENT'S BODY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHILON NYLON SUTURE SUTURE, NON-ABSORBABLE GAR ETHICON, INC. NA CDB015

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK