BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO HERNIA PLUG UNKNOWN PRODUCT

    MDR report key: 11940843 · Received June 4, 2021

    Report

    Report Number
    2210968-2021-05283
    Event Type
    Injury
    Date Received
    June 4, 2021
    Date of Event
    October 12, 2019
    Report Date
    May 6, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K070224
    Adverse Event
    Yes
    Product Problem
    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: 07/02/2021 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 PLUG) 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

    (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: JOURNAL OF JAPAN SURGICAL ASSOCIATION. 2020; 81(1), 115¿120.   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 (TULTRAPRO HERNIA PLUG) 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: A RE-RECURRENT CASE OF INGUINAL BLADDER HERNIA TREATED BY TRANSABDOMINAL PREPERITONEAL REPAIR. THIS STUDY PRESENTS A CASE REPORT OF A (B)(6) YEAR-OLD MALE PATIENT (HEIGHT = 168 CM; WEIGHT =(B)(6) ; BMI = 25.9) WHO COMPLAINED OF A RIGHT INGUINAL BULGE FOR THE PAST 6 MONTHS AND VISITED THE HOSPITAL ON (B)(6) 2019. THE PATIENT UNDERWENT HERNIOPLASTY FOR RIGHT INGUINAL HERNIA AT (B)(6) YEARS (TISSUE REPAIR) AND HERNIOPLASTY FOR RIGHT INGUINAL HERNIA AT (B)(6) YEARS WITH ULTRAPRO PLUG (ETHICON; UPP METHOD). REPORTED COMPLICATION INCLUDED RE-RECURRENT INGUINAL HERNIA WITH BLADDER HERNIA AND UNDERWENT TISSUE REPAIR BY THE TRANSABDOMINAL PREPERITONEAL (TAPP) TECHNIQUE. AN INTRAPERITONEAL VIEW OF THE RIGHT INGUINAL REGION REVEALED THE UPP INSERTED DURING THE PREVIOUS SURGERY MOVED TO THE RIGHT INTERNAL INGUINAL RING AND THE RIGHT MEDIAL UMBILICAL FOLD DRAWN INTO A DEPRESSION ON THE MEDIAL SIDE OF THE RIGHT INFERIOR EPIGASTRIC VESSELS AND THE LATERAL SIDE OF THE RIGHT MEDIAL UMBILICAL FOLD. THE POSTOPERATIVE COURSE WAS UNEVENTFUL WITH NO COMPLICATIONS AND THE PATIENT WAS DISCHARGED ON THE SECOND DAY AFTER SURGERY. PRONE POSITION CT WITH INGUINAL DECOMPRESSION PERFORMED IN THE SIXTH MONTH AFTER SURGERY SHOWED NO RECURRENCE (FIG. 3). IN CONCLUSION, PREOPERATIVE DIAGNOSIS BY PRONE POSITION CT WITH INGUINAL DECOMPRESSION AND DISSECTING WHILE CONSCIOUS OF THE VESICOHYPOGASTRIC FASCIA ARE BOTH IMPORTANT FOR AVOIDING BLADDER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839025 ULTRAPRO HERNIA PLUG UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention