BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 1003261 · Received February 27, 2008

    Report

    Report Number
    2210968-2008-00120
    Event Type
    Death
    Date Received
    February 27, 2008
    Date of Event
    January 5, 2008
    Report Date
    January 30, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    PMA / PMN Number
    N16374
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    REPORTER REPORTED TO AFFILIATE THAT THEY HAD REC'D A REPORT OF A PT WHO EXPIRED THREE DAYS FOLLOWING CARDIAC SURGERY. THE SUTURE WAS USED TO ANASTOMIZE THE CORONARY ARTERY TO A GRAFT. PATIENT WAS RETURNED TO THE OR, AND WHEN THEY OPENED THE CHEST, IT WAS FULL OF BLOOD. THE REPORT STATES THAT THE SUTURE BROKE. NO FURTHER INFO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE POLYPROPYLENE SUTURE SUTURE, NON-ABSORBABLE GAW ETHICON, INC. NA ZKE475

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Death