BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARIETENE

    MDR report key: 9474086 · Received December 16, 2019

    Report

    Report Number
    9615742-2019-03867
    Event Type
    Malfunction
    Date Received
    December 16, 2019
    Date of Event
    December 2, 2019
    Report Date
    April 9, 2020
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: ONE DEVICE WAS RECEIVED FOR EVALUATION. THE VISUAL EXAMINATION OF THE RETURNED SAMPLE SHOWS THAT: THE SAMPLE WAS NOT RETURNED IN ITS ORIGINAL PACKAGING AND PLACED IN A BIOHAZARD BAG. THE DEVICE WAS FOUND NOT CONTAMINATED BY BLOOD. THE TEXTILE KNITTING PATTERN AND THE DEVICE DIMENSION WERE FOUND AS EXPECTED. THE COLLAGEN FILM WAS FOUND BROKEN AT 2 POINTS ON THE OVERLAP AND FOLDED ON ONE EDGE. A KNOT OF THE BLEU YARN WAS FOUND BROKEN. THE REPORTED CONDITION WAS CONFIRMED. ACCORDING TO THE PROCEDURE ¿DEFAULT CHECK¿ A FILM SPLIT WITHOUT PRIMER ON THE TEXTILE IS CONFORM AND THE PRODUCT MAY CONTINUE THE MANUFACTURING PROCESS WITHOUT IMPACT ON THE QUALITY AND SAFETY OF MEDICAL DEVICES. IT SHOULD BE NOTED THAT THE PRODUCT INSTRUCTIONS FOR USE (IFU) STATES IN CHAPTER DESCRIPTION¿ THAT ¿COLORED MONOFILAMENT THREADS MARK THE DEVICE POROUS SIDE¿ AND IN CHAPTER OPERATING STEPS THAT ¿ 3. (¿) THE COLORED THREADS PLACED ON THE TEXTILE SIDE FACILITATE THE DEVICE HANDLING ONCE IT HAS BEEN UNROLLED IN THE ABDOMINAL SPACE. THESE THREADS CAN BE USED FOR THE TRANSPARIETAL FIXING OF THE DEVICE¿. DURING THE MANUFACTURING, A VISUAL EXAMINATION OF EACH DEVICE IS PERFORMED AT SEVERAL STEPS OF THE PROCESS. A PARTICULAR ATTENTION IS DONE DURING THE PACKAGING TO PREVENT THE YARNS FROM BEING IN THE SEALING TRACK. SUCH A DEFECT WOULD HAVE BEEN DETECTED AND THE PRODUCT REJECTED. THE DEFECT SIZE AND THE DEVICE MANIPULATION WERE PROVIDED. IT SHOULD BE NOTED THAT THE DEVICE WAS EXPIRED WHEN IT WAS USED. 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 · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD A LOOSE KNOT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271858 PARIETENE FTL SOFRADIM PRODUCTION SAS PPC2015 POH0096X

    Patients

    Seq Age Sex Outcome Treatment
    1