BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18784836 · Received February 26, 2024

    Report

    Report Number
    2210968-2024-01934
    Event Type
    Injury
    Date Received
    February 26, 2024
    Date of Event
    July 23, 2021
    Report Date
    February 26, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: HERNIA (2022) 26:945¿951. HTTPS://DOI.ORG/10.1007/S10029-021-02443-3.

    Description of Event or Problem · 0

    TITLE: COMPARISON OF TWO FASCIAL DEFECT CLOSURE METHODS FOR LAPAROSCOPIC INCISIONAL HERNIA REPAIR. THIS RETROSPECTIVE COHORT STUDY WAS DESIGNED TO COMPARE INCISIONAL HERNIA DEFECTS REPAIRED WITH LAPAROSCOPIC SUTURE CLOSURE TO A HYBRID APPROACH WITH OPEN DEFECT CLOSURE, BOTH WITH LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH (IPOM) REINFORCEMENT. A TOTAL OF 164 PATIENTS WHO UNDERWENT INCISIONAL HERNIA REPAIR FROM TWO CENTERS, NORTH YORK GENERAL HOSPITAL (NYGH) AND HUMBER RIVER HOSPITAL (HRH) BETWEEN 2015 AND 2020 WERE INCLUDED IN THE STUDY. PATIENTS WERE GROUPED BY TOTALLY LAPAROSCOPIC (N=120; 60 MALE AND 60 FEMALE; MEDIAN AGE WAS 60 (49¿68) YEARS) OR HYBRID FASCIAL CLOSURE (N=44; 20 MALE AND 24 FEMALE; MEDIAN AGE WAS 64 (55¿70) YEARS). BOTH TECHNIQUES INCLUDED LAPAROSCOPICALLY PLACED INTRA-PERITONEAL MESH FROM COMPETITOR WITH 5 CM OF OVERLAP IN ALL DIRECTIONS. IN THE TOTALLY LAPAROSCOPIC GROUP, THE FASCIA OF THE HERNIA DEFECT WAS CLOSED UNDER REDUCED PNEUMOPERITONEUM USING EITHER A RUNNING BARBED SUTURE (VLOCK¿) OR INTERRUPTED FIGURE-OF-EIGHT KNOTS WITH #1 PROLENE SUTURES. THE MEDIAN FOLLOW-UP TIME WAS 1 MONTH (RANGE 1¿7 MONTHS) IN THE LAPAROSCOPIC GROUP AND 3 MONTHS (RANGE 1¿11 MONTHS) IN THE HYBRID GROUP. REPORTED COMPLICATIONS INCLUDE SUPERFICIAL SURGICAL SITE INFECTION (N=1), SEROMA OR HEMATOMA (N=23), PAIN (N=13), AND HERNIA RECURRENCE (N=7). IN CONCLUSION, THESE RESULTS SUGGEST THAT A HYBRID APPROACH TO INCISIONAL VENTRAL HERNIA REPAIR WITH OPEN DEFECT CLOSURE IS COMPARABLE TO A TOTALLY LAPAROSCOPIC CLOSURE. THE HYBRID TECHNIQUE CAN HELP FACILITATE FASCIAL CLOSURE AND RESECTION OF THE HERNIA SAC IN PATIENTS WITH HIGHER BMI AND HERNIA DEFECTS UP TO 6 CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110790 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention