BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX

    MDR report key: 12177411 · Received July 15, 2021

    Report

    Report Number
    9615742-2021-01735
    Event Type
    Injury
    Date Received
    July 15, 2021
    Report Date
    September 5, 2025
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    UDI-DI
    10884521165724
    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

    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

    ADDITIONAL INFO: B5, (&) B7 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE DUE TO FAILURE OF MESH, SEVERE ABDOMINAL PAIN, DIASTASIS OF RECTUS, PAIN, DISCOMFORT, RESTRICTED MOBILITY, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL SURGERY, MEDICATION, HERNIA REPAIR WITH NEW MESH. CONCOMITANT DEVICES: DAVOL - MESH SURGICAL VENTRALIGHT ST 6X8, LOT # HUDW0916, MODEL/CAT # 5954680.

    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 UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE DUE TO FAILURE OF MESH, SEVERE ABDOMINAL PAIN, DIASTASIS OF RECTUS, PAIN, DISCOMFORT, RESTRICTED MOBILITY, ADHESIONS, (&) TENDER ABDOMEN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL SURGERY, MEDICATION, HERNIA REPAIR WITH NEW MESH, (&) PARTIAL REMOVAL OF MESH.

    Additional Manufacturer Narrative · 1

    DAVOL - MESH SURGICAL VENTRALIGHT ST 6X8 MODEL/CAT # 5954680 (LOT# HUDW0916).

    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 IMPLANT, THE PATIENT EXPERIENCED HERNIA RECURRENCE DUE TO FAILURE OF MESH, SEVERE ABDOMINAL PAIN, AND ADHESIONS TO THE FAILED MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072641 PARIETEX MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS PCO8VP PQT0268X 10884521165724

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Disability| R SEE SECTION H10.