BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMACOL

    MDR report key: 18486806 · Received January 10, 2024

    Report

    Report Number
    9615742-2024-00069
    Event Type
    Injury
    Date Received
    January 10, 2024
    Date of Event
    December 18, 2023
    Report Date
    January 10, 2024
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    PMA / PMN Number
    NONE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: 5152-100, 5152-100 PERMACOL 15X20X1.00 X1 (LOT#AVD0904) 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

    ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT SHOWED COMPLETE REJECTION ONE MONTH POST-OP OF THE IMPLANTS, AND HISTOPATHOLOGY EVIDENCE LED TO AN ACUTE INFLAMMATORY REACTION. POST-IMPLANT, THE PATIENT WAS ADMITTED TO THE ICU. THE PATIENT WAS STILL IN THE ICU WITH AN UNKNOWN PERIOD OF STAY. AN ACUTE INFLAMMATORY REACTION LED TO ISCHEMIC BOWEL OPEN ABDOMINAL WALL RECONSTRUCTION AT THE END OF THE RECONSTRUCTIVE STEPS. IT WAS REPORTED THAT THE INCISION WAS EXTENDED BY MORE THAN 1 INCH, WHICH LED TO TISSUE DAMAGE AND HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731607 PERMACOL MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS 5152-100 AVD0904

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O| H