BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH

    MDR report key: 10071308 · Received May 19, 2020

    Report

    Report Number
    9615742-2020-01147
    Event Type
    Injury
    Date Received
    May 19, 2020
    Report Date
    March 28, 2024
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    PMA / PMN Number
    K040998
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO: A4, B5, B7, D4 (EXPIRATION DATE), E1 (FACILITY NAME, STREET, CITY, REGION, POSTAL CODE), H4, H6 (PATIENT CODES, IMF CODES, IME E2402: "IBS, GALLSTONES, CHOLELITHIASIS, CHOLECYSTITIS"). 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 INFORMATION: D7, G4 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA AT THE UMBILICUS. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED INFLAMMATION, RECURRENCE, ADHESIONS, ACUTE CONSTIPATION, DIARRHEA, DISCOMFORT, CHRONIC PAIN, FEVER, SWELLING, NAUSEA, DISTENTION, ABDOMINAL PAIN, IBS, GALLSTONES, CHOLELITHIASIS, SYMPTOMATIC/CHRONIC CHOLECYSTITIS, AND SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, REVISION SURGERY, LYSIS OF ADHESIONS, CHOLECYSTECTOMY, ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH BIOPSIES GEJ AND GASTRIC ANTRUM/BODY, AND HERNIA REPAIR WITH NEW MESH.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PCO12 PARIETEX COMP 3D PY 12 CIR NOTHR (LOT# PLE00299). (B)(4). 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA AT THE UMBILICUS. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS, ACUTE CONSTIPATION, DIARRHEA, DISCOMFORT, CHRONIC PAIN, FEVER, SWELLING, NAUSEA, DISTENTION, ABDOMINAL PAIN, IBS, GALLSTONES, CHOLELITHIASIS, SYMPTOMATIC/CHRONIC CHOLECYSTITIS, AND SUFFERING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, LYSIS OF ADHESIONS, CHOLECYSTECTOMY, ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH BIOPSIES GEJ AND GASTRIC ANTRUM/BODY, AND HERNIA REPAIR WITH NEW MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534624 MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS PCO12 PKH00480

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention