BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX

    MDR report key: 20183408 · Received September 10, 2024

    Report

    Report Number
    9615742-2024-01294
    Event Type
    Injury
    Date Received
    September 10, 2024
    Report Date
    September 10, 2024
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    UDI-DI
    10884521179844
    PMA / PMN Number
    K110663
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6 IME E2402: LABS ABNORMAL FOR CRP, UNABLE TO HAVE BOWEL MOTION 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 IMPLANT, THE PATIENT EXPERIENCED ATROPHIC LATERAL MUSCLES, FEVER, SEROMA, ANXIETY, LABS ABNORMAL FOR CRP, EMESIS, OPEN WOUND WITH BLEEDING, INFLAMMATION WITH SWELLING, HERNIA RECURRENCE, UNABLE TO HAVE BOWEL MOTION, DIAPHORETIC, ABDOMINAL PAIN, DISCOMFORT, & PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, ANTIBIOTICS, EPIDURAL PCA, IV/ORAL PAIN MEDICATION, IV FLUIDS, ANTIEMETICS, DIAZEPAM, WOUND CARE, PHYSIOTHERAPY, & HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330396 PARIETEX MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS PCO3020FX PQD0717X 10884521179844

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H