BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX

    MDR report key: 20483119 · Received October 18, 2024

    Report

    Report Number
    9615742-2024-01485
    Event Type
    Injury
    Date Received
    October 18, 2024
    Report Date
    October 18, 2024
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6 IME E2402: GAS COLLECTION, LAXITY OF RECTUS SHEATH, SCLEROTIC CAPSULE, INDURATION. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    CORRECTION: B5 & ADDED H6 (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 A INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, FLUID COLLECTION, INFECTED MESH, GAS COLLECTION, DIVARICATION OF THE RECTI, SEROMA, LAXITY OF RECTUS SHEATH, SWELLING, REDNESS, WOUND DISCHARGED OF SEROUS FLUID, PUS, LETHARGIC, NIGHT SWEATS, PAIN, DISCOMFORT, SCLEROTIC CAPSULE, ABDOMINAL PAIN, POOR SLEEP DUE TO PAIN, LOW MOOD, ERYTHEMA AB IGNE, ABSCESS, CELLULITIS, SHARP & BURNING PAIN, SUICIDAL IDEATION, MASSES, & INDURATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH MESH, CT SCAN, ULTRASOUND, SEROMA ASPIRATED, ANTIBIOTICS, HOSPITALIZATION, REPAIR OF HERNIA, EXCISION OF ENCAPSULATED SEROMA, USE OF DRAINS, PAIN MEDICATION, USE OF TENS MACHINE, DRAINAGE OF SEROMA, & IV FLUIDS.

    Description of Event or Problem · 0

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE, FLUID COLLECTION, INFECTED MESH, GAS COLLECTION, DIVARICATION OF THE RECTI, SEROMA, LAXITY OF RECTUS SHEATH, SWELLING, REDNESS, WOUND DISCHARGED OF SEROUS FLUID, PUS, LETHARGIC, NIGHT SWEATS, PAIN, DISCOMFORT, SCLEROTIC CAPSULE, ABDOMINAL PAIN, POOR SLEEP DUE TO PAIN, LOW MOOD, ERYTHEMA ABIGNE, ABSCESS, CELLULITIS, SHARP & BURNING PAIN, ABDOMINAL WALL SORE & PARESTHETIC, SUICIDAL IDEATION, MASSES, & INDURATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH MESH, CT SCAN, ULTRASOUND, SEROMA ASPIRATED, ANTIBIOTICS, HOSPITALIZATION, REPAIR OF HERNIA, EXCISION OF ENCAPSULATED SEROMA, USE OF DRAINS, PAIN MEDICATION, USE OF TENS MACHINE, DRAINAGE OF SEROMA, & IV FLUIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043907 PARIETEX MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS PCO2520F PJD00201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R