BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO HERNIA SYSTEM UNKNOWN PRODUCT

    MDR report key: 11347232 · Received February 19, 2021

    Report

    Report Number
    2210968-2021-01592
    Event Type
    Injury
    Date Received
    February 19, 2021
    Date of Event
    August 29, 2018
    Report Date
    January 20, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K071249
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 4/28/2021. 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 DESCRIBED 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

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 2/19/2020 COMPONENT CODE: G07002 - DEVICE NOT RETURNED 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: KITASATO MED J 2019; 49: 16-20   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?

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: CLINICAL ESTIMATION OF THE TAPP LAPAROSCOPIC SURGERY VERSUS THE CONVENTIONAL PROCEDURE FOR INGUINAL HERNIA AND THE EFFICACY OF REDUCING THE NUMBER OF TACKING FIXATIONS OF INTRA-ABDOMINAL DEVICES. THE STUDY DISCUSSED ABOUT THE CLINICAL ESTIMATION OF THE TRANSABDOMINAL PREPERITONEAL (TAPP) LAPAROSCOPIC SURGERY VERSUS THE CONVENTIONAL PROCEDURE FOR INGUINAL HERNIA AND THE EFFICACY OF REDUCING THE NUMBER OF TACKING FIXATIONS OF INTRA-ABDOMINAL DEVICES. A TOTAL OF 134 PATIENTS UNDERWENT EITHER A CONVENTIONAL OPEN PROCEDURE OR TAPP FROM MARCH 2011 THROUGH NOVEMBER 2015. FORTY-FIVE CONVENTIONAL OPEN PROCEDURES (MALE=43, FEMALE=2; MEAN AGE=72.0 ± 12.6 YEARS) AND 89 TAPP PROCEDURES (MALE=77, FEMALE=12; MEAN AGE=68.2 ± 14.3) WERE INCLUDED IN THE STUDY. DURING THE PROCEDURE, POLYPROPYLENE MESH, SUCH AS ULTRAPRO HERNIA SYSTEM (ETHICON), PERFIX LIGHT PLUG, AND KUGEL PATCH WAS USED IN THE CONVENTIONAL GROUP AFTER SPINAL ANESTHESIA. THESE MESHES WERE SHEETED INTO AN OVERLAY AND/OR UNDERLAY OF THE PREPERITONEAL SPACE BY THE ANTERIOR APPROACH AND WERE FIXED WITH STITCHES. REPORTED COMPLICATIONS INCLUDED CORONA MORTIS INJURY (N=?); WOUND INFECTION (N=?); SUBCUTANEOUS HEMATOMA (N=?); CHRONIC PAIN (N=?); AND DISCOMFORT (N=?). IN CONCLUSION, USING THE TAPP PROCEDURE, CHRONIC PAIN WAS SIGNIFICANTLY REDUCED. IT WAS ALSO MADE EVIDENT THAT FEWER TACK POINTS MADE FOR MESH FIXATION IN HERNIA REPAIRS WOULD FURTHER REDUCE DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246029 ULTRAPRO HERNIA SYSTEM UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention