BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO HERNIA SYSTEM UNKNOWN PRODUCT

    MDR report key: 11347253 · Received February 19, 2021

    Report

    Report Number
    2210968-2021-01593
    Event Type
    Injury
    Date Received
    February 19, 2021
    Date of Event
    January 1, 2020
    Report Date
    January 20, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K071249
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). DATE SENT TO THE FDA: 3/24/2021. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCT (ULTRAPRO HERNIA SYSTEM) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBE IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT INVOLVED? 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, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: SCIENTIFIC REPORTS; (2020) 10:3707; DOI: HTTPS://DOI.ORG/10.1038/S41598-020-60722-Y. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCT (ULTRAPRO HERNIA SYSTEM) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT INVOLVED? IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: A RETROSPECTIVE COHORT STUDY OF OPEN PREPERITONEAL REPAIR VERSUS OPEN SUTURE REPAIR FOR THE TREATMENT OF EMERGENCY FEMORAL HERNIA. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE FEASIBILITY OF OPEN PREPERITONEAL REPAIR (OPR) FOR EMERGENCY FEMORAL HERNIAS (FHS) USING ULTRAPRO HERNIA SYSTEM (UHS) MESHES BY COMPARING THE OUTCOMES WITH THOSE OF OPEN SUTURE REPAIR (OSR) FOR THE TREATMENT OF EMERGENCY FHS. FROM 2011 TO 2017, 104 PATIENTS HAD EMERGENCY FHS AND INCLUDED IN THE STUDY. FIFTY ONE PATIENT (MALE=19, FEMALE=32; MEAN AGE=72.4 ± 10.1 YEARS; BMI=18.3 ± 2.5) WERE TREATED WITH OPR AND UHS MESH, AND THE OTHER 53 PATIENTS (MALE=14, FEMALE=39; MEAN AGE=72.5 ± 13.0 YEARS; BMI=18.9 ± 1.8) WERE TREATED WITH OSR WITHOUT MESH. DURING THE PROCEDURE, FOR THE OPR GROUP, THE PREPERITONEAL SPACE WAS FURTHER DISSOCIATED SO THAT THE LOWER LAYER OF THE UHS MESH (ETHICON) COVERED THE ENTIRE MYOPECTINEAL ORIFICE. REPORTED COMPLICATIONS INCLUDED SEROMA (N=7) WHICH WAS WELL ABSORBED DURING THE FOLLOW-UP ACCORDING TO THE ULTRASOUND EXAMINATION; SUPERFICIAL SURGICAL SITE INFECTION (SSI) (N=5) WHICH MOST OF THEM RECOVERED WITHIN 1 MONTH AFTER DRESSING CHANGES; AND RECURRENCE (N=1). IN CONCLUSION, THE REPAIR METHOD OF OPR WITH THE USE OF UHS MESH DID NOT INCREASE THE RISK OF SSI AND WAS SAFE TO APPLY, EVEN IN CONDITIONS WHERE AN EMERGENCY FH OPERATION REQUIRED INTESTINE RESECTION AND ANASTOMOSIS. OPR WITH THE USE OF UHS MESH COULD REDUCE THE RECURRENCE RATE OF POSTOPERATIVE FH AND IMPROVE THE COMFORT AT THE SURGICAL SITE IN EMERGENCY FH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246543 ULTRAPRO HERNIA SYSTEM UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention