BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SUTURE PRODUCT

    MDR report key: 2181815 · Received July 28, 2011

    Report

    Report Number
    2210968-2011-00996
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ETHICON, INC SOMERVILLE
    Product Code
    GAO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: PDS LL PLUS ANTIBACTERIAL SUTURE. PDS II (POLYDIOXANONE) SUTURE. THIS IS ONE OF TWO MEDWATCHES SUBMITTED FOR THIS DEVICE. SEE ALSO MEDWATCH 2210968-2011-00997. THE SAME DEVICE IS REPRESENTED IN EACH MEDWATCH AS IT WAS INVOLVED IN TWO EVENTS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PATIENT UNDERWENT A MIDLINE LAPAROTOMY ON UNKNOWN DATE AND SUTURE WAS USED FOR ABDOMINAL FASCIAL CLOSURE. THE PATIENT EXPERIENCED HEMORRHAGE ON (B)(6) 2011. THE PATIENT UNDERWENT A SECOND LAPAROTOMY AND HEMOSTASIS. THE PATIENT RECOVERED COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SUTURE PRODUCT SUTURE GAO ETHICON, INC SOMERVILLE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention