BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8044999 · Received November 6, 2018

    Report

    Report Number
    2210968-2018-77003
    Event Type
    Injury
    Date Received
    November 6, 2018
    Report Date
    October 18, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT ( PROLENE MESH)INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT INVOLVED?" CITATION: HERNIA (2017) 21:803¿808, DOI 10.1007/S10029-017-1637-4; PUBLISHED ONLINE: 14 AUGUST 2017. (B)(4).

    Description of Event or Problem · 1

    TITLE: GASLESS SINGLE-INCISION LAPAROSCOPIC INGUINAL HERNIA REPAIR: INITIAL EXPERIENCE THE CURRENT STUDY AIMS TO DESCRIBE THE AUTHORS¿ EARLY EXPERIENCE IN GASLESS LAPAROSCOPIC SINGLE-INCISION SURGERY FOR INGUINAL HERNIA REPAIR. FROM APRIL 2010 TO MARCH 2012, 15 CONSECUTIVE CASES (ALL MALES, AGE: 24 TO 80 YEARS) OF GASLESS SINGLE-INCISION TOTALLY EXTRAPERITONEAL (TEP) HERNIA REPAIR WERE PERFORMED. A 30-DEGREE TELESCOPE WAS INSERTED THROUGH THE SUBUMBILICAL WOUND UNDER THE ABDOMINAL WALL RETRACTOR. BY DIRECTLY INTRODUCING TWO MORE 5 MM LAPAROSCOPIC INSTRUMENTS THROUGH THE SUBUMBILICAL WOUND, THE PREPERITONEAL SPACE WAS DISSECTED USING LAPAROSCOPIC DIATHERMY SCISSORS OR ULTRASONIC DISSECTOR (HARMONIC ACE ETHICON US, LLC., CINCINNATI, OH, USA). THE DIRECT INGUINAL HERNIA SAC WAS REDUCED. THE INDIRECT INGUINAL SAC WAS USUALLY LIGATED AND DIVIDED. THE MYOPECTINEAL ORIFICE WAS COVERED WITH A 15 × 15 CM PROLENE MESH (ETHICON, INC., SOMERVILLE, NJ, USA). THE SKIN WOUND WAS CLOSED WITH NYLON STITCHES. NO DRAIN WAS INSERTED. ONE PATIENT DEVELOPED HEMATOMA AND WAS SUCCESSFULLY MANAGED BY SALVAGE LAPAROSCOPIC RE-OPERATION. IN CONCLUSION, GASLESS SINGLE-INCISION TEP IS FEASIBLE WITH FAVORABLE RESULTS. THIS TECHNIQUE CAN BE ALSO APPLIED TO HIGH-RISK PATIENTS WITH COMPROMISED CARDIORESPIRATORY STATUS AND THOSE WITH INCARCERATED INGUINAL HERNIA REQUIRING BOWEL RESECTION. FUTURE LARGE SCALE RANDOMIZED STUDY IS NEEDED TO VERIFY THE EFFECTIVENESS OF THIS TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880754 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention