BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 1197691 · Received October 14, 2008

    Report

    Report Number
    2210968-2008-00989
    Event Type
    Injury
    Date Received
    October 14, 2008
    Date of Event
    May 16, 2008
    Report Date
    September 10, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 10/10/2008. (WOUND DEHISCENCE OCCURRED) - NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THE ACTUAL DEVICE ASSOCIATED WITH THIS EVENT IS NOT KNOWN. INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE PRODUCTS: LOT: 967696, MFG: 03/01/2008, EXP 03/31/2013; LOT: 970088, MFG: 03/01/2008, EXP 03/31/2013. THIS IS ONE OF TWO MEDWATCH REPORTS BEING SUBMITTED AS TWO SEPARATE DEVICES WERE USED. SEE 2210968-2008-00990 FOR THE OTHER MEDWATCH. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT UNDERWENT A CHOLESTECTOMY. THE PATIENT PRESENTED WITH AN ABDOMINAL WOUND DEHISCENCE TWO DAYS POST-OP. THE PATIENT WAS RETURNED TO SURGERY FOR REPAIR. THE SURGEON REPORTS THAT TWO OF THREE SUTURES "RUPTURED" IN THE MIDDLE OF THE INCISION. ADDITIONAL INFORMATION WAS REQUESTED; NO FURTHER INFORMATION 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