BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

    MDR report key: 3072881 · Received April 23, 2013

    Report

    Report Number
    2210968-2013-04310
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 5, 2013
    Manufacturer
    ETHICON, INC
    Product Code
    GAS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN INCISIONAL HERNIA PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED TO SECURE THE GORE DUALMESH IN PLACE. ONE WEEK POST-OPERATIVELY, THE PATIENT RETURNED TO SURGERY TO HAVE THE SURGICAL WOUND WASHED DUE TO AN ABDOMINAL WOUND INFECTION. THE PATIENT WAS READMITTED WITH A TIA AND CELLULITIS OF THE SKIN NEAR THE INCISION. ON (B)(6) 2013, THE PATIENT WAS SEEN IN THE OFFICE WITH SEROMA DRAINAGE AND WOUND SEPARATION WITH FIBRINOUS EXUDATE. ON (B)(6) 2013, THE PATIENT UNDERWENT WOUND EXPLORATION AND SHARP DEBRIDEMENT OF EXTENSIVE AND DEEP FIBRINOUS EXUDATE INCLUDING COVERING OF THE MESH. THE PATIENT IS STABLE POST-OPERATIVE, AND POSSIBLY WILL NEED TO HAVE THE MESH EXPLANTED. CULTURE RESULTS ARE PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174274 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE SUTURE, NON-ABSORBABLE GAS ETHICON, INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention