BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PARIETEX PRODUCT

    MDR report key: 17625034 · Received August 25, 2023

    Report

    Report Number
    9615742-2023-01231
    Event Type
    Injury
    Date Received
    August 25, 2023
    Date of Event
    February 20, 2023
    Report Date
    August 25, 2023
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: UNKABSTACK, UNKNOWN ABSORBATACK (LOT#UNK) TITLE: LAPAROENDOSCOPIC SINGLE-SITE INGUINAL HERNIORRHAPHY: EXPERIENCE OF A SINGLE INSTITUTE SOURCE: JOURNAL OF CLINICAL MEDICINE 2023, 12, 1786. HTTPS://DOI.ORG/ 10.3390/JCM12051786 / WEI-QUEN TEE, YEN-TING WU, HUNG-JEN WANG, YAO-CHI CHUANG, WEI-CHIA LEE, CHIA-HUNG TSAI, LONG-YUAN LEE AND CHIEN-HSU CHEN. PUBLISHED: 23 FEBRUARY 2023. 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 LITERATURE, A RETROSPECTIVE STUDY EVALUATED THE OUTCOMES OF PATIENTS WHO UNDERWENT THE LAPARO-ENDOSCOPIC SINGLE-SITE TOTAL EXTRAPERITONEAL HERNIORRHAPHY FOR INGUINAL HERNIORRHAPHY BETWEEN JANUARY 2014 AND JULY 2021. A 15X10CM HYDROPHILIC ANATOMICAL MESH WAS USED IN 121 PATIENTS AND DID NOT REQUIRED FIXATION. A COMPETITOR MESH WAS USED IN 167 PATIENTS AND WAS FIXED USING AN ABSORBABLE TACK FIXATION DEVICE. POSTOPERATIVE COMPLICATIONS INCLUDED: SEROMA, PAIN, DELAYED ABSCESS AND HERNIA RECURRENCE. PAIN WAS TREATED WITH ORAL PAINKILLERS AND SEROMA REQUIRED FINE-NEEDLE PERCUTANEOUS ASPIRATION IN TWO PATIENTS. ONE PATIENT EXPERIENCED A DELAYED MESH ABSCESS 3 YEARS POSTOPERATIVELY AND UNDERWENT MESH REMOVAL AND DEBRIDEMENT. ONE PATIENT EXPERIENCED RECURRENCE AND UNDERWENT OPEN HERNIORRHAPHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2076581 UNKNOWN PARIETEX PRODUCT Mesh, surgical, polymeric FTL SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention PLEASE SEE NOTE ON H10