BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19033309 · Received April 3, 2024

    Report

    Report Number
    2210968-2024-03805
    Event Type
    Injury
    Date Received
    April 3, 2024
    Date of Event
    January 1, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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: JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES. VOLUME 33, NUMBER 9, 2023. HTTPS://DOI.ORG/10.1089/LAP.2023.0147.

    Description of Event or Problem · 0

    TITLE: ASSESSMENT OF SURGICAL AND QUALITY-OF-LIFE OUTCOMES BETWEEN LAPAROSCOPIC VERSUS OPEN INGUINAL HERNIA REPAIR IN GERIATRIC PATIENTS. THE AIM OF THE STUDY WAS TO INVESTIGATE WHETHER INGUINAL HERNIA SURGERY CAN BE PERFORMED SAFELY IN ELDERLY PATIENTS COMPARED WITH THE NORMAL POPULATION AND ESPECIALLY IF LAPAROSCOPIC HERNIA SURGERY CAN BE PERFORMED SAFELY. BETWEEN JANUARY 2017 TO NOVEMBER 2019 A TOTAL OF 79 PATIENTS (71 MALE AND 8 FEMALE) WITH A MEAN AGE OF 71.83 YEARS WERE INCLUDED IN THE STUDY. THESE PATIENTS PRESENTED WITH INGUINAL HERNIAS, AND UNDERWENT SURGERY. ALL PATIENTS WERE DIVIDED IN TWO GROUPS; GROUP 1 (TAPP GROUP) TREATED WITH TRANSABDOMINAL PREPERITONEAL TECHNIQUE (TAPP) USING A POLYPROPYLENE MESH WITH SIZE 15X10 CM, AND THE PERITONEUM WAS THEN CLOSED WITH 3/0 VICRYL SUTURES. GROUP 1 CONSISTS 45 PATIENTS (40 MALE AND 5 FEMALE) AND A MEAN AGE OF 72.37 YEARS. GROUP 2 (LH GROUP) HAD LICHTENSTEIN HERNIA (LH) REPAIR USING A POLYPROPYLENE MESH WITH SIZE 10X8 CM, AND MESH WAS FIXED WITH 3/0 POLYPROPYLENE TO THE INGUINAL LIGAMENT. GROUP 2 HAD 34 PATIENTS (31 MALE AND 3 FEMALE) WITH A MEAN AGE OF 71.29 YEARS. RECORDED COMPLICATIONS WERE: 5 PATIENTS HAD SEROMA, 1 PATIENT WITH HEMATOMA, 1 PATIENT WITH CHRONIC GROIN PAIN, AND 1 PATIENT WITH URINARY RETENTION. CONCLUSION: THE STUDY SUGGESTS THAT LAPAROSCOPIC INGUINAL HERNIA SURGERY CAN BE SAFELY PERFORMED IN ELDERLY PATIENTS WITH LOWER COMPLICATION RATES AND FASTER RECOVERY TIMES COMPARED WITH OPEN SURGERY. THE ADVANTAGES OF LAPAROSCOPIC SURGERY, SUCH AS LOWER PO PAIN SCORES AND FASTER RECOVERY TIMES, WERE ALSO OBSERVED IN ELDERLY PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1544853 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention