BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

    MDR report key: 255769 · Received December 23, 1999

    Report

    Report Number
    2210968-1999-00586
    Event Type
    Injury
    Date Received
    December 23, 1999
    Date of Event
    August 23, 1996
    Report Date
    December 13, 1999
    Manufacturer
    ETHICON, INC. SAN LORENZO
    Product Code
    GAS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF THAT IN 1996 SHE UNDERWENT A LAPAROTOMY WHICH WAS REPAIRED WITH ETHIBOND SUTURES. IN 1996, SHE UNDERWENT AN EXPLORATORY LAPAROTOMY FOR THE REPAIR OF A VERY LARGE VENTRAL HERNIA WITH A MARLEX MESH. (THE MESH IS NOT AN ETHICON PRODUCT). THE PLAINTIFF ALLEGES THAT AFTER THE SECOND OPERATION SHE DEVELOPED AN INFECTION WITHIN THE MARLEX MESH, RESULTING FROM THE ETHIBOND SUTURES USED ON THE FIRST OPERATION, AND FURTHER RESULTING IN THE NEED FOR RECURRENT SURGERIES.

    Description of Event or Problem · 1

    MEDICAL RECORDS INDICATE IN 1996 THAT THE PT UNDERWENT REPAIR OF VENTRAL HERNIA USING MARLEX MESH AND ETHIBOND SIZE 0. ON 8/23/1996, PT WAS RE ADMITTED SECONDARY TO PURULENT DRAINAGE FROM WOUND AND WOUND SEPARATION. INCISION WAS HEALING WELL. ON 12/3/19969 THE PHYSICIAN STATED THAT THE WOUND WAS COMPLETELY HEALED EXCEPT FOR A ONE TO TWO CM AREA BELOW THE UMBILICUS. WOUND WAS DEDRIDED THE PURULENT TISSUE AND EXCISED SOME MARLEX MESH ALONG WITH A SUTURE. SUBSEQUENTLY AS ABSCESS FORMED WHICH INCLUDED SEVERAL SUTURES. SUTURES AND MESH WERE REMOVED. IN 1997, ADD'L DEBRIDEMENT WITH REMOVAL OF ETHIBOND SUTURES WERE PERFORMED. THE PT CONTINUED TO EXPERIENCE CHRONIC HERNIAS WITH DIFFICULTY IN HEALING AND "STITCH ABSCESS", RECURRENT WOUND INFECTIONS AND POSSIBLE TOLERANCE TO POLYESTER SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE Implant SUTURE, NON-ABSORBABLE GAS ETHICON, INC. SAN LORENZO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention