BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX

    MDR report key: 12067493 · Received June 25, 2021

    Report

    Report Number
    9615742-2021-01561
    Event Type
    Injury
    Date Received
    June 25, 2021
    Report Date
    June 11, 2024
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    UDI-DI
    10884521179837
    PMA / PMN Number
    K110815
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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: A4, A5A, B2, B5, B6, B7, <(>&<)> H6 (PATIENT CODES, IME E2402: LABS ABNORMAL FOR ALBUMIN; HEMOGLOBIN; HEMATOCRIT; PH; PCO2; PO2; CREATININE; CO2, INDURATION, FLUCTUANCE) 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 THE IMPLANT, THE PATIENT EXPERIENCED PAIN, MESH INFECTION, DESE ADHESIONS, HERNIA RECURRENCE, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL, AND REVISION SURGERY. CONCOMITANT DEVICES: STRATTICE 30CMX30CM- PRODUCT ID: 3039002, LOT #: 8P200041, EXP. DATE: 2020-08-31.

    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 THE IMPLANT, THE PATIENT EXPERIENCED PAIN, MESH INFECTION, DENSE ADHESIONS, HERNIA RECURRENCE, ABDOMINAL PAIN, INFLAMMATION, SEROMA, PERFORATION ABDOMINAL WALL DEHISCENCE WITH EVISCERATION, ABSCESSES, SEPTIC SHOCK. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, MESH REMOVAL, REVISION SURGERY, DIAGNOSTIC LAPAROSCOPY, LYSIS OF ADHESIONS, EXPLORATORY LAPAROTOMY, PLACEMENT OF VAC, MOBILIZATION OF BILATERAL MYOCUTANEOUS FLAPS, HERNIA REPAIR WITH MESH.

    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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, MESH INFECTION, DENSE ADHESIONS, HERNIA RECURRENCE, ABDOMINALPAIN, INFLAMMATION, SEROMA, PERFORATION ABDOMINAL WALL DEHISCENCE WITH EVISCERATION OF BOWEL, ABSCESSES, SEPTIC SHOCK, FLUID COLLECTION, STAPH, LABS ABNORMAL FOR ALBUMIN; HEMOGLOBIN; HEMATOCRIT; PH; PCO2; PO2; CREATININE; CO2; SODIUM, CELLULITIS, REACTIVE MULTINUCLEATED GIANT CELL REACTION, SWELLING, DRAINAGE FROM WOUND, DISCOMFORT, PURULENT FLUID, SCAR TISSUE, BLEEDING, TENDERNESS, SEPSIS, FEVER, COUGH, ACUTE CHRONIC KIDNEY INJURY, TACHYCARDIA, LOW BLOOD PRESSURE, ERYTHEMA, INDURATION, <(>&<)> FLUCTUANCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION, MESH REMOVAL, REVISION SURGERY, DIAGNOSTIC LAPAROSCOPY, LYSIS OF ADHESIONS, EXPLORATORY LAPAROTOMY, PLACEMENT OF VAC, MOBILIZATION OF BILATERAL MYOCUTANEOUS FLAPS, HERNIA REPAIR WITH MESH, CT SCAN, INTERVENTIONAL RADIOLOGY/ULTRASOUND GUIDED DRAIN PLACEMENT, IV FLUIDS, ANTIBIOTICS, WOUND CARE, HOSPITALIZATION, ICU, INCISION AND DRAINAGE OF ABSCESS, <(>&<)> PAIN MEDICATION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: STRATTICE 30CMX30CM- PRODUCT ID 3039002, LOT # 8P200041, EXP. DATE 2020-08-31. 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 MESH INFECTION, DESE ADHESIONS, HERNIA RECURRENCE, AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL, AND REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964627 PARIETEX MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS PCO2520X PSA0867X 10884521179837

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H| L