BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 1942381 · Received December 23, 2010

    Report

    Report Number
    2210968-2010-01732
    Event Type
    Death
    Date Received
    December 23, 2010
    Date of Event
    November 1, 2010
    Report Date
    December 2, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    PMA / PMN Number
    N16374
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 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 PT UNDERWENT A BYPASS SURGICAL PROCEDURE ON AN UNK DATE AND SUTURE WAS USED. ANASTOMOSIS OPENED POST-OPERATIVELY, THE SUTURE HAD BROKEN. THE PT BLED TO DEATH AND PASSED AWAY ON (B)(6) 2010 IN THE INTENSIVE CARE UNIT. A POST MORTEM EXAMINATION WAS PERFORMED ON (B)(6) 2010. ADDITIONAL INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE POLYPROPYLENE SUTURE SUTURE, NON-ABSORBABLE GAW ETHICON, INC. NA CGP012

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death