BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO HERNIA SYSTEM UNKNOWN PRODUCT

    MDR report key: 11355899 · Received February 20, 2021

    Report

    Report Number
    2210968-2021-01618
    Event Type
    Injury
    Date Received
    February 20, 2021
    Date of Event
    January 1, 2019
    Report Date
    January 21, 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: QIN ET AL. JOURNAL OF CARDIOTHORACIC SURGERY (2019) 14:118; DOI: HTTPS://DOI.ORG/10.1186/S13019-019-0938-3. 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 COMPARATIVE STUDY OF THORACOSCOPIC AND OPEN SURGERY OF CONGENITAL DIAPHRAGMATIC HERNIA IN NEONATES. THIS RETROSPECTIVE STUDY DISCUSSED ABOUT A COMPARATIVE STUDY OF THORACOSCOPIC AND OPEN SURGERY OF CONGENITAL DIAPHRAGMATIC HERNIA IN NEONATES. FROM 2015 TO 2018, A TOTAL OF 70 CHILDREN WITH CONGENITAL DIAPHRAGMATIC HERNIA (CDH) WERE ENROLLED IN THE STUDY. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: 26 CASES (MALE=10, FEMALE=16; MEAN AGE= 15.3 ± 2.1 DAY) RECEIVED THORACOSCOPIC-ASSISTED DIAPHRAGMATIC HERNIA REPAIR (OBSERVATION GROUP) AND 44 CASES (MALE=19, FEMALE=25; MEAN AGE=14.7 ± 2.8) RECEIVED OPEN DIAPHRAGMATIC HERNIA REPAIR (CONTROL GROUP). IN OBSERVATION GROUP, DURING PROCEDURE, THE HERNIA CONTENTS WERE REPOSITIONED TO THE ABDOMINAL CAVITY, AND THE DIAPHRAGM DEFECT WAS FULLY EXPOSED IN ORDER TO OBSERVE THE SIZE OF THE DIAPHRAGM DEFECT. IF THERE IS A HERNIA SAC IN THE CHILD, PUSH IT TO THE ABDOMINAL SIDE, AND THEN USE 2¿0 NON-ABSORBABLE NEEDLE SUTURE TO SUTURE THE DEFECT DIAPHRAGM INTERMITTENTLY. THE PATCH USES A NEW TYPE OF LIGHTWEIGHT ULTRAPRO HERNIA SYSTEM (UHS) DEVICE (ETHICON) TO SUTURE THE DEFECT FROM BOTH SIDES OF THE SMALL TENSION TO THE MIDDLE. AFTER SUTURING, THE OPERATING INSTRUMENTS WERE PULLED OUT AND THE INCISION WAS SUTURED. REPORTED COMPLICATIONS INCLUDED PULMONARY INFECTION (N=3); INCISION INFECTION (N=2); PULMONARY HYPERTENSION (N=3); SCLEREDEMA (N=1); RECURRENCE (N=3). IN CONCLUSION, THE INTRAOPERATIVE HEMODYNAMIC PARAMETERS OF CDH REPAIR UNDER THORACOSCOPY WERE MORE STABLE, THE DURATION OF POSTOPERATIVE MECHANICAL VENTILATION, ANTIBIOTIC USE AND HOSPITALIZATION WERE SHORTENED, AND THE THERAPEUTIC EFFECT WAS BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252870 ULTRAPRO HERNIA SYSTEM UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention