BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 17471259 · Received August 7, 2023

    Report

    Report Number
    2210968-2023-05646
    Event Type
    Injury
    Date Received
    August 7, 2023
    Date of Event
    March 5, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. AN ATTEMPT HAS BEEN 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. RELATED EVENTS CAPTURED VIA 2210968-2023-05645 AND 2210968-2023-05647. CITATION: CLINICAL TRANSPLANTATION. 2023;37:E14969. DOI: 10.1111/CTR.14969.

    Description of Event or Problem · 0

    TITLE: SAFETY OF LAPAROSCOPIC REPAIR OF INCISIONAL HERNIAS IN LIVER TRANSPLANT RECIPIENTS. THIS RETROSPECTIVE COHORT STUDY AIMED TO INVESTIGATE WHETHER LAPAROSCOPIC INCISIONAL HERNIA REPAIR (LIHR) AFTER LIVER TRANSPLANT IS SAFE AND TO EVALUATE SHORT AND LONG-TERM OUTCOMES OF LIHR IN COMPARISON TO THE TRADITIONAL OPEN APPROACH. BETWEEN FEBRUARY 1991 AND SEPTEMBER 2020, 240 INCISIONAL HERNIAS WERE DIAGNOSED FROM A TOTAL OF 1877 LIVER TRANSPLANTS (12%). FROM 2010 ONWARDS, 138 PATIENTS UNDERWENT INCISIONAL HERNIA REPAIRS POST-LIVER TRANSPLANT WERE INCLUDED IN THE STUDY. LIVER TRANSPLANTS WERE PERFORMED THROUGH A REVERSE-L, MERCEDES BENZ, OR MIDLINE INCISION ACCORDING TO PATIENT FACTORS SUCH AS PREVIOUS SURGERY AND SURGICAL PREFERENCE. WOUND CLOSURE WAS IN LAYERS WITH 1/PDS LOOP RUNNING SUTURE, AND SKIN CLOSURE WITH SKIN STAPLES. DURING INCISIONAL HERNIA REPAIR, THE PATIENTS WERE DIVIDED INTO 2 GROUPS ACCORDING TO THE APPROACH USED: 40 PATIENTS (34 WERE MALES; MEAN AGE OF 56 ±8 YEARS; MEAN BMI OF 31 ± 6) WERE PERFORMED USING LAPAROSCOPIC APPROACH AND 98 PATIENTS (78 WERE MALES; MEAN AGE OF 54 ± 8 YEARS; MEAN BMI OF 28 ± 4) HAD OPEN REPAIR. REPAIR WAS PERFORMED USING EITHER A PROLENE MESH OR A VENTRALIGHT®INTRAPERITONEAL ONLAY MESH (IPOM), WHICH WAS SECURED BENEATH THE HERNIA DEFECT IN THE SUBLAY POSITION USING ETHICON SECURESTRAP® TACKING. REPORTED COMPLICATIONS POST-TRANSPLANT INCLUDE INCISIONAL HERNIA (N=240), WOUND INFECTION (N=20), AND WOUND DEHISCENCE (N=3). POST-INCISIONAL HERNIA REPAIR COMPLICATIONS INCLUDE WOUND INFECTION (N=?), HERNIA RECURRENCE (N=?), MESH INFECTIONS (N=?), BOWEL PERFORATION (N=?), INTRAABDOMINAL HEMATOMA (N=?), BILE DUCT INJURIES (N=?), AND INTRAABDOMINAL COLLECTION (N=?). IN CONCLUSION, LAPAROSCOPIC REPAIR OF LARGER INCISIONAL HERNIAS REDUCED POSTOPERATIVE LENGTH OF HOSPITAL STAY, WHILST POTENTIAL ADVANTAGES MAY INCLUDE REDUCED WOUND COMPLICATIONS AND HERNIA RECURRENCE. IMPORTANTLY, LAPAROSCOPIC REPAIR DID NOT INCREASE POSTOPERATIVE COMPLICATION RATES AND REPRESENTS A SAFE TECHNIQUE FOR REPAIR IN THIS DEMOGRAPHIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467098 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention