BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 1060358 · Received June 12, 2008

    Report

    Report Number
    2210968-2008-00438
    Event Type
    Death
    Date Received
    June 12, 2008
    Report Date
    May 13, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    PMA / PMN Number
    N16374
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    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 ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THE ACTUAL DEVICE ASSOCIATED WITH THIS EVENT IS NOT KNOWN. CUSTOMER REPORTS THE FOLLOWING POSSIBLE PRODUCTS: LOT: AAR113, MFG: 01/27/2008, EXP: 01/31/2013. LOT: ABE770, MFG: 02/13/2008, EXP: 01/31/2013. LOT: ACE025, MFG: 03/10/2008, EXP: 01/31/2013.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1