BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MESH PRODUCT

    MDR report key: 25086877 · Received May 5, 2026

    Report

    Report Number
    9615742-2026-00502
    Event Type
    Injury
    Date Received
    May 5, 2026
    Date of Event
    August 6, 2025
    Report Date
    May 5, 2026
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN (B)(6) 2025, THE PATIENT UNDERWENT HERNIA REPAIR SURGERY INVOLVING THE IMPLANTATION OF A MESH. THE PATIENT HAD POST -OPERATIVE CONCERNS, HOWEVER IN A SUBSEQUENT POST-OPERATIVE OFFICE VISIT IN (B)(6) 2025, NO COMPLICATIONS WERE IDENTIFIED BY THE PHYSICIAN AND NO ADDITIONAL DIAGNOSTIC IMAGING WAS ORDERED. THE PATIENT WAS SEEN BY THE PHYSICIAN AGAIN AT THE FACILITY WHEREIN THE PATIENT DISCLOSED A PRIOR HERNIA REPAIR PERFORMED IN THE (B)(6) 1970S AND STATED THAT MESH WAS NOT BELIEVED TO HAVE BEEN USED. AN ULTRASOUND IMAGING FROM (B)(6) 2025 REPORTEDLY SHOWED NO EVIDENCE OF PRIOR MESH IMPLANTATION. BASED ON THE PHYSICIAN¿S EXAMINATION, THE PATIENT WAS INFORMED THAT FINDINGS APPEARED NORMAL. HOWEVER, IN THE MONTHS FOLLOWING SURGERY, THE PATIENT¿S CONDITION FAILED TO IMPROVE. THE PATIENT REPORTED CONSTANT PAIN, LOSS OF NORMAL FUNCTION, AND A DRASTIC DECLINE IN QUALITY OF LIFE, INCLUDING DEPRESSION AND ISOLATION. THE PATIENT¿S CONDITION AND APPEARANCE CONTINUED TO WORSEN AND IN (B)(6) 2026, AFTER THE ONSET OF BLEEDING, THE PATIENT SOUGHT CARE AT AN URGENT CARE FACILITY. DIAGNOSTIC IMAGING, INCLUDING ULTRASOUND AND CT (COMPUTED TOMOGRAPHY) SCANS, WERE PERFORMED, AND REFERRALS TO SURGICAL AND UROLOGY SPECIALISTS WERE MADE. AN EVALUATION OF A SURGEON STATED THAT THE PATIENT¿S CONDITION AS UNUSUAL AND COMPLEX DESCRIBING IT AS ¿A REAL MESS¿.  THE PATIENT LATER VISITED THE EMERGENCY DEPARTMENT OVERNIGHT AND WAS ADVISED TO OBTAIN A REFERRAL FOR A SECOND OPINION, WHICH WAS DENIED. THE PATIENT THEN SOUGHT A UROLOGIST WHICH STATED THAT THE PATIENT HAS A SUPRAPUBIC/BLADDER MASS. THE AFTER-VISIT SUMMARY DOCUMENTED THAT IT WAS UNCLEAR WHETHER THE MASS WAS RELATED TO IMPLANTED MESH OR TO CANCER OR OTHER CAUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404736 UNKNOWN MESH PRODUCT MESH, SURGICAL FTM SOFRADIM PRODUCTION SAS UNKNOWN MESH PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| H