BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX

    MDR report key: 20183362 · Received September 10, 2024

    Report

    Report Number
    9615742-2024-01293
    Event Type
    Injury
    Date Received
    September 10, 2024
    Report Date
    September 10, 2024
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    PMA / PMN Number
    K173796
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10 (BARD PERMAFIX FIXATION 36 CM X2, PRODUCT ID - 0113120, LOT # - HUWG0955). 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 HERNIA RECURRENCE, DIVARICATION OF THE RECTI, FLUID COLLECTION, LABS ABNORMAL FOR CRP, ATROPHIC LATERAL MUSCLES, DISCOMFORT, ADHESIONS, FEVER, SEROMA, ANXIETY, EMESIS, OPEN WOUND WITH BLEEDING, INFLAMMATION WITH SWELLING, UNABLE TO HAVE BOWEL MOTION, DIAPHORETIC, PAIN, <(>&<)> ABDOMINAL PAIN. POST OPERATIVE TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, CT SCAN, HOSPITALIZATION, EXCESS SAC EXCISED, ANTIBIOTICS, EPIDURAL PCA, ORAL PAIN MEDICATION, IV FLUIDS, ANTIEMETICS, DIAZEPAM, WOUND CARE, <(>&<)> PHYSIOTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329385 PARIETEX MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS PCO3728FX PND0528

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H11 COMMENT