BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMBOTEX

    MDR report key: 12137909 · Received July 8, 2021

    Report

    Report Number
    9615742-2021-01686
    Event Type
    Injury
    Date Received
    July 8, 2021
    Report Date
    April 2, 2025
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    UDI-DI
    10884521190375
    PMA / PMN Number
    K142908
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO: A2 (DATE OF BIRTH), A3A, A4, B2 (ADDED INTERVENTION REQUIRED, REMOVED OTHER), B5, B7, D1, D4 (MODEL #, CATALOG #, EXPIRATION DATE, LOT #, UDI #), G4 (510K #), H4, H6 (PATIENT CODE, IMF CODES). 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: B5, H6 (REMOVED PATIENT CODE). 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

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED LIMITED RANGE OF MOTION, DEFECTIVE MESH, PAIN, SUFFERING, SEVERE EMOTIONAL DISTRESS, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, LOSS OF CARE, MENTAL PAIN, AND DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

    Description of Event or Problem · 0

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED LIMITED RANGE OF MOTION, DEFECTIVE MESH, PAIN, SUFFERING, SEVERE EMOTIONAL DISTRESS, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN, AND DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED LIMITED RANGE OF MOTION, DEFECTIVE MESH, PAIN, SUFFERING, SEVERE EMOTIONAL DISTRESS, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, LOSS OF CARE, MENTAL PAIN, DISTRESS, AND LOSS OF COMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030955 SYMBOTEX MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS SYM1510 PPK0535X 10884521190375

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Disability| O| R