BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 1202732 · Received October 16, 2008

    Report

    Report Number
    2210968-2008-01003
    Event Type
    Injury
    Date Received
    October 16, 2008
    Date of Event
    September 13, 2008
    Report Date
    September 17, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    PMA / PMN Number
    N16374
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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. THE ACTUAL DEVICE ASSOCIATED WITH THIS EVENT IS NOT KNOWN. INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE PRODUCTS: LOT: XLR757, MFG: 10/01/2006, EXP: 07/31/2011. LOT: ZME769, MFG: 11/01/2007, EXP: 07/31/2012.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT A NEEDLE DETACHED FROM THE SUTURE DURING A MITRAL VALVE REPAIR. A MISSING NEEDLE WAS NOTED DURING THE NEEDLE COUNT AT THE END OF THE PROCEDURE. THE SURGEON RE-OPENED THE PT, AND REMOVED A RETAINED NEEDLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention