BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18774941 · Received February 25, 2024

    Report

    Report Number
    2210968-2024-01865
    Event Type
    Injury
    Date Received
    February 25, 2024
    Date of Event
    April 1, 2021
    Report Date
    February 25, 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
    HR
    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: SURG LAPAROSC ENDOSC PERCUTAN TECH . VOL 31 ( XX ): 150-154. HTTPS://JOURNALS.LWW.COM/SURGICAL-LAPAROSCOPY/ABSTRACT/2021/04000/PERCUTANEOUS_INTERNAL_RING_SUTURING_FOR_THE.5.ASPX.

    Description of Event or Problem · 0

    TITLE: PERCUTANEOUS INTERNAL RING SUTURING FOR THE MINIMAL INVASIVE TREATMENT OF PEDIATRIC INGUINAL HERNIA: A 5-YEAR SINGLE SURGEON EXPERIENCE. THE AIM OF THIS STUDY WAS TO EVALUATE THE MANAGEMENT AND POSTOPERATIVE OUTCOMES OF PIRS FOR INGUINAL HERNIA REPAIR IN CHILDREN. A TOTAL OF 188 PEDIATRIC PATIENTS WHO UNDERWENT HERNIA REPAIR USING THE PIRS TECHNIQUE IN THE PERIOD FROM FEBRUARY 2015 TO FEBRUARY 2020 WERE ENROLLED IN THIS PROSPECTIVE COHORT STUDY. THERE WERE 126 (67%) MALE INDIVIDUALS AND 66 (33%) FEMALE INDIVIDUALS. THE MEDIAN AGE OF THE PATIENTS AT THE TIME OF SURGERY WAS 4 YEARS. THROUGH THE SAME SKIN INCISION, THE SAME NEEDLE WAS INTRODUCED, BUT ON THE OTHER SIDE OF THE INTERNAL RING, PASSING THROUGH THE PREVIOUSLY INTRODUCED LOOP (FIG. 1C). NYLON SUTURE (PROLENE 3-0, POLYPROPYLENE, ETHICON, CINCINNATI, OH) WAS INTRODUCED THROUGH THE NEEDLE. THE REPORTED COMPLICATIONS INCLUDED INFERIOR EPIGASTRIC VEINS INJURIES IN INTRAOPERATIVE COMPLICATIONS (N=3), HYDROCELE (N=3), AND SWELLING OF THE TISSUES AROUND THE UPPER POLE OF THE GROIN (N=2). IN CONCLUSION, IN A HANDS OF AN EXPERIENCED PEDIATRIC LAPAROSCOPIC SURGEON, PIRS IS A SIMPLE, SAFE, AND EFFECTIVE TECHNIQUE FOR INGUINAL HERNIA REPAIR IN CHILDREN WITH EXCELLENT OUTCOMES, COSMETIC RESULTS, AND A LOW INCIDENCE OF COMPLICATIONS AND RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212560 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention