BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX

    MDR report key: 11794700 · Received May 7, 2021

    Report

    Report Number
    9615742-2021-01021
    Event Type
    Injury
    Date Received
    May 7, 2021
    Report Date
    February 5, 2024
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    UDI-DI
    10884521179820
    PMA / PMN Number
    K110816
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO: B2, B5, B6, B7, G1, H6 (PATIENT CODES, DEVICE CODES, IME E2402: LABS ABNORMAL FOR WBC; HEMOGLOBIN; HEMATOCRIT; ELEVATED D-DIMER; ALBUMIN; PROTEIN; LACTATE, LABS ABNORMAL FOR CREATININE; PLATELETS, THICKENED LARGE BOWEL, FOCAL COLITIS, ATEL ECTASIS, LEUKOCYTOSIS, GAS-FILLED LOOP OF BOWEL, COLON THICKENED, DIFFICULTY BREATHING). 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.

    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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, FAILURE OF MESH, MESH FOLDED BACK AND RECEDED, SEROMA, MESH MIGRATION, FAILURE TO INCORPORATE, DILATED SMALL, LARGE BOWEL LOOPS, BOWEL OBSTRUCTION, LABS ABNORMAL FOR WBC; HEMOGLOBIN; HEMATOCRIT; ELEVATED D-DIMER; ALBUMIN; PROTEIN; LACTATE; POTASSIUM; SODIUM; CREATININE; PLATELETS, THICKENED LARGE BOWEL, ISCHEMIC BOWEL, FOCAL COLITIS, ATELECTASIS/PNEUMONIA, SMALL BILATERAL PLEURAL EFFUSIONS, ASCITES, LEUKOCYTOSIS, ABSCESS, STAPH, GAS-FILLED LOOP OF BOWEL, LOCULATED FLUID, COLON THICKENED, INFLAMMATION, ADHESIONS, SEROUS FLUID DRAINAGE, WEAKNESS, DIFFICULTY BREATHING, NAUSEA, ABDOMINAL PAIN, DEHYDRATION, TACHYCARDIA, DISTENTION, ERYTHEMA, ACUTE KIDNEY INJURY, CELLULITIS, LOW BLOOD PRESSURE, OPEN WOUND DRAINING SEROPURULENT CLOTS, WOUND INFECTION, PUS, WOUND DEHISCED, EDEMA, ANXIETY. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL SURGERY, X-RAY, CT SCAN, HOSPITALIZATION, IV FLUID RESUSCITATION, IV ANTIBIOTICS, IV PAIN, IV ANTI-NAUSEA MEDICATION, NG TUBE, ELECTROLYTE REPLACEMENT, DRAINAGE OF ABDOMINAL WALL INFECTION, REMOVAL OF RETAINED SUTURES, DEBRIDEMENT, IRRIGATION, WOUND VAC, PICC LINE INSERTION, IV FLUIDS, NPO, BLOOD TRANSFUSION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICE: BARD OPTIFIX FIXATION, LOT #: HUDZ0773, PRODUCT ID: 0113126. 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 AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, FAILURE OF MESH, MESH FOLDED BACK AND RECEDED, SEROMA, MESH MIGRATION, AND FAILURE TO INCORPORATE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688262 PARIETEX MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS PCO2520OSX PQG1330X 10884521179820

    Patients

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