BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 10741912 · Received October 27, 2020

    Report

    Report Number
    2210968-2020-08353
    Event Type
    Injury
    Date Received
    October 27, 2020
    Date of Event
    August 14, 2018
    Report Date
    October 6, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. 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. DOES THE AUTHOR/SURGEON BELIEVE THAT ETHICON PRODUCTS (PROLENE SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE AUTHOR/SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (PROLENE SUTURE) USED IN THIS PROCEDURE? WERE THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? CITATION: WORLD J GASTROENTEROL 2018 AUGUST 14; 24(30): 3440-3447; DOI: 10.3748/WJG.V24.I30.3440 IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    TITLE: APPLICATION OF MODIFIED PRIMARY CLOSURE OF THE PELVIC FLOOR IN LAPAROSCOPIC EXTRALEVATOR ABDOMINAL PERINEAL EXCISION FOR LOW RECTAL CANCER THE AIMED OF THIS RETROSPECTIVELY STUDY WAS TO INTRODUCE A NOVEL, MODIFIED PRIMARY CLOSURE TECHNIQUE OF LAPAROSCOPIC EXTRALEVATOR ABDOMINAL PERINEAL EXCISION (LELAPE) FOR LOW RECTAL CANCER. FROM MARCH 2013 TO MAY 2016, 76 PATIENTS WITH RECTAL CANCER UNDERWENT LELAPE. PATIENTS WERE CLASSIFIED INTO THE MODIFIED PRIMARY CLOSURE GROUP (MALE=32, FEMALE=8; MEAN AGE=52.8 ± 12.2 YEARS; MEAN BMI=26.8 ± 3.2) AND THE BIOLOGICAL MESH CLOSURE GROUP (MALE=31, FEMALE=13; MEAN AGE=58.2 ± 12.5 YEARS; MEAN BMI=25.7 ± 2.7). DURING PROCEDURE IN BIOLOGICAL MESH CLOSURE, A HUMAN ACELLULAR DERMAL MATRIX MESH WAS IMPLANTED AND FIXED TO THE TENDINOUS ARCH BY CONTINUOUS PROLENE SUTURES (ETHICON) FOR RECONSTRUCTION OF THE PELVIC FLOOR. REPORTED COMPLICATIONS INCLUDED INTESTINAL OBSTRUCTION (N=1) AT 40 DAYS (D) IN WHICH CONSERVATIVE THERAPY DID NOT WORK AND A LAPAROSCOPIC EXPLORATION WAS PERFORMED AT 42 D. THE PATIENT WAS HEALED BY DECOMPRESSION OF THE SMALL INTESTINE AND INTESTINAL REARRANGEMENT UNDER LAPAROTHOMY; INTRAOPERATIVE BLOOD LOSS (MEAN=149 ± 52 ML) (N=?); CLEAR OR HAEMOSEROUS DISCHARGE FROM PERINEAL WOUND (N=1); PUS/PURULENT DISCHARGE FROM PERINEAL WOUND (N=2); DEEP INFECTION WITH OR WITHOUT TISSUE BREAKDOWN FROM PERINEAL WOUND (N=2). THE PATIENTS WHO HAD PERINEAL WOUND INFECTIONS HAD RECOVERED WITHIN 60D AFTER APPROPRIATE TREATMENT; POSTOPERATIVE FEELING OF BULGE (N=2) AT 12 MONTHS. IN CONCLUSION, THE MODIFIED PRIMARY CLOSURE METHOD FOR RECONSTRUCTION OF THE PELVIC FLOOR IN LELAPE FOR LOW RECTAL CANCER IS TECHNICALLY FEASIBLE, SAFE, AND COST-EFFECTIVE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204524 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention