BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 13546752 · Received February 16, 2022

    Report

    Report Number
    2210968-2022-01144
    Event Type
    Injury
    Date Received
    February 16, 2022
    Date of Event
    April 7, 2021
    Report Date
    February 16, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: HERNIA (2021); 25:1635¿1646. HTTPS://DOI.ORG/10.1007/S10029-021-02397-6. EVENTS RELATED TO PDS II POLYDIOXANONE SUTURE REPORTED VIA MW # 2210968-2022-00799.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: E-TEP REPAIR FOR MIDLINE PRIMARY AND INCISIONAL HERNIA: TECHNICAL CONSIDERATIONS AND INITIAL EXPERIENCE. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO PRESENT THE AUTHORS' INITIAL EXPERIENCE OF THIS APPROACH AND DETAILED STEPS OF THEIR NATIVE TECHNICAL MODIFICATIONS IN OVERCOMING THE CHALLENGES IN PERFORMING THIS COMPLEX AND POTENTIALLY CHALLENGING PROCEDURE. A TOTAL OF 58 PATIENTS (31 MALE AND 27 FEMALE; MEAN AGE OF 53.8±11 YEARS; MEAN BMI OF 29.3±4 KG/M2) WHO UNDERWENT ENHANCED-VIEW TOTALLY EXTRA PERITONEAL RIVES-STOPPA (E-TEP-RS) WITH AND WITHOUT TRANSVERSUS ABDOMINIS RELEASE (TAR) FOR MIDLINE, LARGE, COMPLEX, VENTRAL ABDOMINAL HERNIAS BETWEEN MARCH 2018 AND DECEMBER 2019 WERE INCLUDED IN THE STUDY. SURGERY WAS PERFORMED USING 12 MM EXCEL TROCAR (ETHICON), 5 MM EXCEL TROCAR (ETHICON), AND HARMONIC SCALPEL (ETHICON). ANY ACCIDENTAL HOLES IN THE PERITONEUM ARE CLOSED USING 3¿0 PDS INTERRUPTED SUTURES. A SOFT PROLENE MESH (ETHICON) WAS USED IN 6 CASES WHILE AN UNKNOWN MEDIUM OR HEAVY WEIGHT POLYPROPYLENE MESH WAS USED IN THE REST OF THE CASES. FOLLOW-UP RANGED FROM 6 TO 22 MONTHS, WITH A MEAN OF 14 MONTHS. REPORTED COMPLICATIONS INCLUDE HERNIA RECURRENCE (N=1), MESH SENSATION AFTER 1 MONTH (N=?), AND CHRONIC PAIN (N=?) REQUIRING ANALGESICS. IN CONCLUSION, THE E-TEP-RS TECHNIQUE FOR LARGE, COMPLEX, MIDLINE, VENTRAL ABDOMINAL HERNIAS CAN BE USED WITH EXCELLENT RESULTS AND ACCEPTABLE MORBIDITY. THIS TECHNIQUE IS TECHNICALLY CHALLENGING AND SHOULD BE MASTERED IN RELATIVELY SMALLER VENTRAL HERNIAS TO ACHIEVE GOOD RESULTS BEFORE ATTEMPTING IT IN LARGER, COMPLEX ONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566807 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention