BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPRO HRN MSH 10CM U/LAY

    MDR report key: 22284677 · Received June 18, 2025

    Report

    Report Number
    2210968-2025-07050
    Event Type
    Injury
    Date Received
    June 18, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K071249
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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. D4/G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THEREFORE, (01)GTIN IS NOT AVAILABLE. TO DATE IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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. ADDITIONAL INFORMATION: B7. CORRECTED INFORMATION: D4, D6A. ADDITIONAL INFORMATION RECEIVED: (B)(4). EVENT DATE: 13 JUNE 2022. IMPLANTATION OF TWO INGUINAL PROSTHESES THUS BILATERAL, PAIN AND NEGATIVE CONSEQUENCES SINCE IMPLANTATION. YPE OF ANESTHESIA: GENERAL ANESTHESIA. CLINICAL REMINDER: THIS PATIENT HAS A HISTORY OF LEFT VARICOCELE, PILONIDAL CYST, TRAMADOL INTOLERANCE AND CODEINE. HE ACTUALLY PRESENTS A LEFT INGUINAL HERNIA, NOT COMPLICATED ON THIS DAY. TESTICLES ARE IN PLACE. AN ULTRASOUND WAS PERFORMED THAT FOUND A LEFT INGUINAL HERNIA. IN ADDITION, THE PATIENT HAS INGUINAL PAIN ON THE RIGHT AND ON ULTRASOUND, THERE IS ACTUALLY A SMALL ONE INGUINAL HERNIA THAT IS SMALL. THE PATIENT WISHES TO HAVE SURGERY ON BOTH SIDES. THE PROCEDURE AND ITS COMPLICATIONS WERE EXPLAINED IN PATIENT IN PARTICULAR THE RISK OF BLEEDING, THE RISK OF INFECTION, INGUINAL PAIN AND RECURRENCE. GESTURES PERFORMED: UNDER GENERAL ANESTHESIA, PLACING THE PATIENT IN A DECKCHAIR POSITION. LEFT INGUINAL INCISION. WE TAKE BACK THE OLD SCAR. OPENING OF THE APONEUROSIS OF THE SUPERIOR OBLIQUE MUSCLE. DISSECTION OF CORD ELEMENTS ON A LAKE. THERE IS A DIRECT HERNIA. WE DISSECTED IN THE PREPE1ITONEAL RETRO-MUSCULAR SPACE. PLACEMENT OF A LARGE UHS PROSTHESIS WHICH WAS FIXED BY PROLENE STITCHES 2/0. CLOSURE OF THE APONEUROSIS ANTERIOR. SUBCUTANEOUS THREAD AND GLUE TO THE SKIN. FOR THE REST, WE MAKE A RIGHT INGUINAL INCISION. OPENING APONEUROSIS OF THE SUPERIOR OBLIQUE MUSCLE. DISSECTION OF CORD ELEMENTS ON A LAKE. DISSECTION OF A HERNIAL LIPOMA. THERE IS A DOUBLE DIRECT AND INDIRECT HERNIA WHOSE SAC HAS BEEN RESECTED. SUBSEQUENTLY, PLACEMENT OF A UHS PROSTHESIS LARGE IN THE PREPERITONEAL RETRO-MUSCULAR SPACE FIXED BY PROLENE POINTS 2/0. CLOSURE OF THE APONEUROSIS ANTERIOR. THREAD UNDER THE SKIN AND GLUE. CURRENT STATE OF THE PATIENT: VERY SEVERE DISABLING PAIN SINCE IMPLANTATION, INGUINAL PAIN, TESTICULAR PAIN, SEVERE DIGESTIVE DISORDERS AND TOTAL DISABILITY (PROFESSIONAL, PERSONAL LIFE), CHRONIC FATIGUE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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. ADDITIONAL INFORMATION: H4, H6. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIA PROCEDURE ON (B)(6) 2022 AND MESH WAS IMPLANTED. PAIN WAS NOTED FOLLOWING PLACEMENT. INCREASED PAIN IN THE LEFT TESTICLE, DIGESTIVE PROBLEMS, PAIN IN THE GROIN AND LOWER ABDOMEN (BURNING, PULLING) THAT IS DEBILITATING. CHRONIC FATIGUE, DEPRESSION WERE ALSO REPORTED. NO IMPROVEMENT DESPITE SEVERAL PROPOSED SOLUTIONS, FAILURE. VERSATIS PATCH, TENS, QUTENZA PATCH SUGGESTED BY A PAIN MANAGEMENT DOCTOR. INJECTION WAS UNNECESSARY AND INCREASED THE PAIN. NO FURTHER INFORMATION IS AVAILABLE OR COULD BE OBTAINED AS REPORTER DETAILS HAVE NOT BEEN DISCLOSED (CONFIDENTIAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1767637 UPRO HRN MSH 10CM U/LAY MESH, SURGICAL, POLYMERIC FTL ETHICON INC. SBBDMDB0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other