BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

    MDR report key: 3082783 · Received April 29, 2013

    Report

    Report Number
    2210968-2013-04641
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 11, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAT
    PMA / PMN Number
    N17804
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: IT WAS REPORTED THAT INITIALLY, THE SUTURE WAS USED ON THE MUSCLE FASCIA WITH NO COMPLICATIONS. AT THE TIME OF SURGERY, THE PATIENT WAS GIVEN ANCEF IV. THE PATIENT DEVELOPED REDNESS, DRAINAGE AND WAS NOT HEALING UNTIL THE SUTURE WAS REMOVED. ON (B)(6) 2011, KENALOG WAS INJECTED INTO THE UMBILICAL SCAR. ON (B)(6) 2011, THE SUTURE KNOT WAS EXCISED AT THE UPPER LEFT UMBILICUS AREA WHICH CONTINUES TO DRAIN. ON (B)(6) 2011, THE SUTURE WAS REMOVED. ON (B)(6) 2012, A LESION WAS EXCISED WITH A COMPLEX CLOSURE. ON (B)(6) 2012, THE PATIENT UNDERWENT A SCAR REVISION AND SUTURE REMOVAL. ON (B)(6) 2013, SUTURES WERE REMOVED. ON (B)(6) 2013, SUTURES WERE REMOVED. ONCE SUTURE WAS EXTRACTED, DRAINAGE WOULD RESOLVE AND SOFT TISSUE WOULD HEAL. (B)(4) - REDNESS.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE WITH LOCAL ANESTHESIA ON (B)(6) 2013 TO REMOVE SPITTING SUTURE. THIS REMOVAL INCISION HAD TO BE DONE TO THE RIGHT SIDE OF THE BELLY BUTTON, WHERE LARGE KNOT HAD FORMED, WHICH CAUSED BRUISING AND SCARING WITH NO INFECTION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE SUTURE WAS PLACED IN THE ABDOMEN AND WAS SPITTING FROM THE LOWER AND MIDDLE ABDOMEN. TWICE THE PATIENT UNDERWENT LOCAL ANESTHESIA AND EXTRACTION OF SUTURE THROUGH THE BELLY BUTTON. THE PATIENT ALSO UNDERWENT GENERAL ANESTHESIA WITH EXTRACTION OF SUTURE THROUGH LOWER ABDOMEN AND BELLY BUTTON. ANOTHER PROCEDURE WITH LOCAL ANESTHESIA AND EXTRACTION OF SUTURE THROUGH THE BELLY BUTTON IS PLANNED FOR (B)(6) 202013 DUE TO GRANULOMAS. ALSO, THE PATIENT HAD 3-4 MORE SUTURE PIECES THAT CAME TO THE SURFACE WITHOUT INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S HUSBAND THAT THE PATIENT UNDERWENT AN ABDOMINOPLASTY PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. APPROXIMATELY THREE MONTHS FOLLOWING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURES WERE NOT ABSORBING AND COMING TO THE SURFACE OF THE SKIN. THE PATIENT REQUIRED ADDITIONAL SURGERIES TO REMOVE THE SUTURES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183422 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE SUTURE, NONABSORBABLE GAT ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention