BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8934757 · Received August 27, 2019

    Report

    Report Number
    2210968-2019-86275
    Event Type
    Injury
    Date Received
    August 27, 2019
    Report Date
    July 31, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. CITATION: BRITISH JOURNAL OF SURGERY 2006; 93: 1549¿1553 / DOI: 10.1002/BJS.5485. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: LAPAROSCOPIC INCISIONAL HERNIA REPAIR WITH A SELF-CENTRING SUTURE". AUTHOR/S: R. W. MOTSON, A. H. ENGLEDOW, C. MEDHURST, R. ADIB AND S. J. WARREN. CITATION: BRITISH JOURNAL OF SURGERY 2006; 93: 1549¿1553 / DOI: 10.1002/BJS.5485 . THE PURPOSE OF THIS STUDY WAS TO DISCUSS LONG-TERM RESULTS ON LAPAROSCOPIC INCISIONAL HERNIA REPAIR WITH A SELF-CENTRING SUTURE. BETWEEN JAN 1995 AND JAN 2005, 117 CONSECUTIVE PATIENTS [N=50 MEN, N=67 WOMEN, MEDIAN AGE 68 YEARS (RANGE 31-91 YEARS)] UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIRS. AFTER FULL LAPAROSCOPIC ASSESSMENT OF THE ABDOMINAL CAVITY, ADHESIOLYSIS WAS PERFORMED USUALLY USING SHARP SCISSOR DISSECTION AND MONOPOLAR DIATHERMY. A HARMONIC SCALPEL (ULTRACISION, ETHICON) WAS USED ONLY WHEN DENSE ADHESIONS WERE ENCOUNTERED. THE DIAMETER OF THE DEFECT, OR DEFECTS, WAS MEASURED AND A PROLENE MESH PATCH (ETHICON) OF SUFFICIENT SIZE TO OVERLAP THE DEFECT BY AT LEAST 3 CM ON ALL SIDES WAS PREPARED. A 10-CM 0/0 PROLENE SUTURE (ETHICON) WITH A STRAIGHT NEEDLE WAS SUTURED TO THE CENTRE OF THE MESH. THE MESH WAS ROLLED UP AROUND THE STRAIGHT NEEDLE BEFORE INSERTION INTO THE ABDOMINAL CAVITY VIA A 10-MM PORT. THE MESH WAS UNROLLED, AND THE NEEDLE WAS GRASPED AND DIRECTED TOWARDS THE CENTRE OF THE DEFECT. IT WAS THEN PASSED THROUGH THE PERITONEAL SAC AND SUBCUTANEOUS TISSUE TO EMERGE THROUGH THE ANTERIOR ABDOMINAL WALL. EXTRA-ABDOMINAL TRACTION ON THE SUTURE CENTRED THE MESH OVER THE DEFECT(S). FINALLY, THE SUTURE WAS CUT EXTRA ABDOMINALLY. POSTOPERATIVE COMPLICATIONS INCLUDED BLEEDING (N=1) WHICH REQUIRED A LAPAROTOMY; SEROMAS (N=14) WHICH WERE SUCCESSFULLY TREATED BY NEEDLE ASPIRATION; HAEMATOMA (N=1) WHICH REQUIRED DRAINAGE; SMALL BOWEL OBSTRUCTION (N=1) WHICH SETTLED IN WITH CONSERVATIVE MANAGEMENT; CHRONIC DEBILITATING PAIN (N=3) REQUIRING PAIN TEAM MANAGEMENT; AND RECURRENCE (N=9). LAPAROSCOPIC INCISIONAL HERNIA REPAIR USING A SELF-CENTRING SUTURE PROVIDES GOOD LONG-TERM RESULTS WITH LOW COMPLICATION RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731553 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention