BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHILON NYLON SUTURE

    MDR report key: 1821312 · Received August 26, 2010

    Report

    Report Number
    2210968-2010-00970
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 27, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAR
    PMA / PMN Number
    N85316
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM..

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN EXPLORATORY LAPAROTOMY PROCEDURE ON (B)(6) 2010. DURING THE PROCEDURE, THE NEEDLE BROKE. THE PIECES WERE REMOVED DURING THE SAME PROCEDURE AND THE CASE WAS COMPLETED WITH ANOTHER TYPE OF SUTURE. THERE WERE NO ADVERSE PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHILON NYLON SUTURE SUTURE, NON-ABSORBABLE GAR ETHICON, INC. NA CEB127

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK