BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7661693 · Received July 3, 2018

    Report

    Report Number
    2210968-2018-74082
    Event Type
    Injury
    Date Received
    July 3, 2018
    Report Date
    June 8, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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: OBES SURG (2008) 18:1387¿1391; DOI 10.1007/S11695-008-9488-9. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: THE REPAIR OF INCISIONAL HERNIA FOLLOWING ROUX-EN-Y GASTRIC BYPASS¿WITH OR WITHOUT CONCOMITANT ABDOMINOPLASTY? AUTHOR(S): A. ILJIN & D. SZYMANSKI & J. KRUK-JEROMIN & J. STRZELCZYK. CITATION: OBES SURG (2008) 18:1387¿1391; DOI 10.1007/S11695-008-9488-9. THE AIM OF THIS STUDY WAS TO EVALUATE THE RESULTS OF SIMULTANEOUS INCISIONAL HERNIA REPAIR AND ABDOMINOPLASTY COMPARED WITH HERNIA REPAIR ALONE IN PATIENTS FOLLOWING ROUX-EN-Y GASTRIC BYPASS (RYGB) FOR MORBID OBESITY. FROM 1999 TO 2006, 204 PATIENTS UNDERWENT OPEN ROUX-EN-Y GASTRIC BYPASS FOR MORBID OBESITY AND 32 PATIENTS WERE DIAGNOSED WITH INCISIONAL HERNIA POSTOPERATIVELY. THESE PATIENT WERE ALLOCATED INTO TWO GROUPS: GROUP 1 (N=14; N=4 MALE AND 10 FEMALE; MEAN AGE OF 37.2 YEARS) ¿ PATIENTS UNDERGOING HERNIA REPAIR WITHOUT ABDOMINOPLASTY AND GROUP 2 (N=18; N=6 MALE AND N=12 FEMALE; MEAN AGE OF 43.7 YEARS) ¿ PATIENTS UNDERGOING HERNIA REPAIR WITH ABDOMINOPLASTY. IN BOTH GROUPS (HERNIA REPAIR), A POSTERIOR SHEATH OF THE ABDOMINAL RECTUS MUSCLE WAS DETACHED AND A POLYPROPYLENE MESH 8 CM WIDE AND 2 CM LONGER THAN THE ACTUAL WOUND LENGTH WAS CONNECTED TO ONE OF ITS MARGINS WITH INTERRUPTED, PROLENE SUTURES, AND BEFORE CLOSING THE PERITONEUM, PROLENE INTERRUPTED SUTURES WERE PLACE ON THE OPPOSITE SHEATH MARGIN UNDER A VISUAL CONTROL. IN GROUP 1, COMPLICATIONS INCLUDED WOUND INFECTION (N=3) AND WOUND FISTULA WITH HERNIA RECURRENCE IN A LOWER WOUND END (N=1). IN GROUP 2, COMPLICATIONS INCLUDED WOUND INFECTION (N=3) WHICH REQUIRED EXCISION OF THE WOUND MARGINS AND RE-SUTURING. IN THE SAME GROUP 6-8 MONTHS FOLLOWING SURGERY, OCCURRENCE OF TRANSIENT DYSESTHESIA (N=10) AND PERMANENT DYSESTHESIA (N=1) WERE NOTED. INFECTION IS THE MOST FREQUENT COMPLICATION OF INCISIONAL HERNIA REPAIR WITH THE USE OF THE POLYPROPYLENE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499729 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention