BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 21292119 · Received February 3, 2025

    Report

    Report Number
    2210968-2025-01210
    Event Type
    Injury
    Date Received
    February 3, 2025
    Date of Event
    January 1, 2024
    Report Date
    February 3, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES. HTTPS://DOI.ORG/10.1089/LAP.2023.0434.

    Description of Event or Problem · 0

    TITLE: THE OPTIMAL SUTURE BITE DEPTH IN LAPAROSCOPIC PYELOPLASTY: A COMPARATIVE STUDY IN CHILDREN. THE AIM OF PROSPECTIVELY STUDY WAS TO ANALYZE THE OPTIMAL SUTURE BITE DEPTH IN LAPAROSCOPIC ANDERSON-HYNES PYELOPLASTY. BETWEEN JULY 2019 TO JULY 2022, A TOTAL OF 90 CHILDREN (70 BOYS AND 20 GIRLS, AGE 4¿14 YEARS) WITH UPJO-INDUCED HYDRONEPHROSIS WHO WERE SURGICALLY TREATED WITH THE MODIFIED ANDERSON-HYNES PYELOPLASTY. ABOUT 1- AND 0.5-MM SUTURE BITE DEPTHS WERE MADE IN GROUP A AND B DURING THE SUTURE OF RENAL PELVIS TO URETER, RESPECTIVELY. THE SUTURE THICKNESS AND TIGHTNESS OF THE SUTURE WERE MADE AS THE SAME AS POSSIBLE. THE SUTURE BITE DEPTH WAS MEASURED REFERRING TO THE DIAMETER OF THE 2-0 SUSPENDED PROLENE SUTURE (F = 0.3 MM). ALL PATIENTS WERE FOLLOWED UP THROUGH MEASURING ADP AT 3, 6, AND 9 MONTHS POSTOPERATIVELY REPORTED COMPLICATIONS INCLUDE PATIENTS: - ANASTOMOTIC STENOSIS (N=4) TREATMENT= PATIENTS RECEIVED REPLACEMENT OF A DOUBLE-J STENT. EXCEPT FOR 1 REOPERATED PATIENT WITH ANASTOMOTIC STENOSIS CAUSED BY THE MASSIVE EXTRAVASATION OF URINE. 3 PATIENTS WAS SUCCESSFULLY REMOVED AT 3 MONTHS, AND THE SYMPTOMS OF ANASTOMOTIC STENOSIS DISAPPEARED. IN CONCLUSION, COLLECTIVELY, OUR DATA SUGGESTED THAT AN APPROPRIATE DEEPER SUTURE BITE DEPTH IN LAPAROSCOPIC PYELOPLASTY OF CHILDREN WITH UPJO-INDUCED HYDRONEPHROSIS CAN INCREASE THE SUCCESS RATE OF THE SURGERY, LOWER THE INCIDENCE OF POSTOPERATIVE COMPLICATIONS, AND REDUCE THE PAIN AND MEDICAL COST. A LEAK-FREE ANASTOMOSIS OF THIN URETERS IN CHILDREN REQUIRES A THOROUGH RESEARCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170269 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention