BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 8915859 · Received August 21, 2019

    Report

    Report Number
    2210968-2019-85930
    Event Type
    Injury
    Date Received
    August 21, 2019
    Report Date
    July 30, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: INT UROL NEPHROL (2007) 39:989¿993; DOI 10.1007/S11255-007-9186-X; PUBLISHED ONLINE: 1 MARCH 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: FLANK HERNIA AND BULGING AFTER OPEN NEPHRECTOMY: MESH REPAIR BY FLANK OR MEDIAN APPROACH? REPORT OF A NOVEL TECHNIQUE. THIS STUDY REPORTS A FLANK HERNIA SURGICAL REPAIR EITHER WITH A FLANK INCISION OR A MEDIAN LAPAROTOMY WITH THE IMPLANTATION OF A PROSTHETIC MESH IN A SUBLAY TECHNIQUE AND COMPARE AND EVALUATE PROSPECTIVE FOLLOW-UP STUDY IN TERMS OF THEIR LONG-TERM RESULTS. FROM 1997 TO 2006, 15 FLANK HERNIA REPAIRS WITH A PROSTHETIC MESH IMPLANTATION WERE PERFORMED. FROM 1997 TO 2001, SEVEN PATIENTS (MEAN AGE 56±17 YEARS, MALE N=4, FEMALE N=3) WITH FLANK HERNIAS WERE MANAGED WITH A STANDARDIZED MESH IMPLANTATION THROUGH THE INITIAL FLANK INCISION (FLANK GROUP). SINCE 2001, EIGHT PATIENTS (MEAN AGE 53±11 YEARS, MALE N=5, FEMALE N=3) HAVE UNDERGONE A HERNIA REPAIR THROUGH A MEDIAN LAPAROTOMY WITH THE USE OF A PROSTHETIC MESH OVERLAPPING THE MIDLINE IN A SUBLAY TECHNIQUE (MEDIAN GROUP). IN THE FLANK GROUP, A POLYPROPYLENE MESH [PROLENE, ETHICON ENDO-SURGERY (EUROPE) GMBH, NORDERSTEDT, GERMANY] WAS IMPLANTED, WHICH WAS FIXATED WITH AN INTERRUPTED BRAIDED POLYESTER SUTURE [ETHIBOND, ETHICON ENDO-SURGERY (EUROPE) GMBH, NORDERSTEDT, GERMANY]. IN THE MEDIAN GROUP, FOLLOWING CLOSURE OF THE POSTERIOR RECTUS SHEATH WITH A RUNNING ABSORBABLE POLYDIOXANONE LOOP SUTURE [PDS II, ETHICON ENDO-SURGERY (EUROPE) GMBH, NORDERSTEDT, GERMANY], A POLYPROPYLENE MESH [PROLENE, ETHICON ENDO-SURGERY (EUROPE) GMBH, NORDERSTEDT, GERMANY] AND AFTER 2003 A LIGHTWEIGHT AND PARTIALLY ABSORBABLE MESH [VYPRO AND ULTRAPRO, ETHICON ENDO-SURGERY (EUROPE) GMBH, NORDERSTEDT, GERMANY] WAS PLACED AND FIXED WITH SUTURES ON THE POSTERIOR RECTUS SHEATH. THE ANTERIOR RECTUS SHEATH WAS THEN CLOSED WITH AN ABSORBABLE POLYDIOXANONE LOOP SUTURE [PDS II, ETHICON ENDO-SURGERY (EUROPE) GMBH, NORDERSTEDT, GERMANY]. COMPLICATIONS IN THE FLANK GROUP INCLUDED SEROMA (N=6), WOUND INFECTION (N=2), SUBILEUS (N=1), RECURRENCE (N=2) AND PERSISTENT FLANK BULGE (N=7). COMPLICATIONS IN THE MEDIAN GROUP INCLUDED SEROMA (N=5), WOUND INFECTION (N=1). IN CONCLUSION, SURGICAL REPAIR OF AN INCISIONAL FLANK HERNIA WITH THE USE OF A PROSTHETIC MESH EXTENDING TO THE CONTRALATERAL ABDOMINAL WALL IS A SAFE AND EFFECTIVE METHOD THAT ENABLES A REMODELING ABDOMINAL WALL. COMPARED TO OUR DESCRIBED NOVEL TECHNIQUE THE LAPAROSCOPIC APPROACH HAS ADVANTAGES AS FAR AS THE OPERATIVE TRAUMA IS CONCERNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710284 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention