BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 1295131 · Received January 23, 2009

    Report

    Report Number
    2210968-2009-00079
    Event Type
    Injury
    Date Received
    January 23, 2009
    Date of Event
    November 1, 2008
    Report Date
    December 3, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    PMA / PMN Number
    N16374
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. THE ACTUAL DEVICE ASSOCIATED WITH THIS EVENT IS NOT KNOWN. INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE PRODUCTS: CODE: 8434T, LOT: 131269, MFG: 10/28/2008, EXP: 10/31/2013. CODE: 8424T, LOT: 132933, MFG: 11/03/2008, EXP: 11/30/2013. 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.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT THE SUTURE BROKE APPROXIMATELY 24 HRS FOLLOWING AN EXPLORATORY LAPAROTOMY. THE PATIENT WAS RETURNED TO SURGERY FOR REPAIR. THE PATIENT WAS REPORTEDLY COUGHING OR VOMITING AT THE TIME OF THE REPORTED EVENT. ADDITIONAL INFO WAS REQUESTED; NO FURTHER INFO WAS RECEIVED.

    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