BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SUTURE PRODUCT

    MDR report key: 2181855 · Received July 28, 2011

    Report

    Report Number
    2210968-2011-00997
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ETHICON, INC SOMERVILLE
    Product Code
    GAK
    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 2210968-2011-00996. THE SAME DEVICE IS REPRESENTED IN EACH MEDWATCH AS IT WAS INVOLVED IN TWO EVENTS.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2011. THE PATIENT WAS TREATED WITH CEFTRIAXON AND METRONIDAZOL. THE CURRENT STATUS OF THE PATIENT IS GOOD GENERAL CONDITION, STILL RECEIVING OUTPATIENT TREATMENT, AND THE WOUND OF THE MEDIAN LAPAROTOMY IS HEALED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A MIDLINE LAPAROTOMY ON UNKNOWN DATE AND SUTURE WAS USED FOR ABDOMINAL FASCIAL CLOSURE. THE PATIENT DEVELOPED AN INFECTION ON (B)(6) 2011 AND WAS TREATED WITH ANTIBIOTICS. THE PATIENT (B)(6) OUTCOME WAS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention