BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 2934670 · Received December 21, 2012

    Report

    Report Number
    2210968-2012-08392
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 20, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    GAT
    PMA / PMN Number
    N16374
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NO INFORMATION

    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 EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A GENERAL SURGERY PROCEDURE ON (B)(6) 2012. PRIOR TO USE ON THE PT, WHEN TRYING TO SHAKE THE SUTURE FROM THE PACKAGE, THE SUTURE WAS FOUND TO BE IN THE SIDE SEAL OF THE PACKAGE. THE SUTURE WAS NOT USED ON THE PT. ANOTHER LIKE DEVICE WAS USED WITH NO ADVERSE PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE POLYPROPYLENE SUTURE SUTURE, NON-ABSORBABLE GAT ETHICON, INC. NA EKB929

    Patients

    Seq Age Sex Outcome Treatment
    1 NI