BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PROGRIP MESH PRODUCT

    MDR report key: 17767648 · Received September 18, 2023

    Report

    Report Number
    9615742-2023-01298
    Event Type
    Injury
    Date Received
    September 18, 2023
    Date of Event
    November 24, 2020
    Report Date
    September 18, 2023
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE: LAUREN BLAHA, KONSTANTINOS CHOULIARAS, ANDREW WHITE, STEPHEN MCNATT, AND CARL WESTCOTT, 2020, INTRAOPERATIVE BOTULINUM TOXINCHEMODENERVATION AND ANALGESIA IN ABDOMINAL WALL RECONSTRUCTION. SURGICAL INNOVATION 2021, VOL. 28(6) 706¿713, DOI: 10.1177/1553350620975253, JOURNALS.SAGEPUB.COM/HOME/SRI. 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 SOURCE OF STUDY PERFORMED BETWEEN 2015 AND 2019, A RETROSPECTIVE REVIEW WAS TO ANALYZE THE IMPACT OF BOTULINUM TOXIN CHEMODENERVATION ON POSTOPERATIVE OPIATE CONSUMPTION THROUGH A NOVEL INTRAOPERATIVE INJECTION PROTOCOL. THERE WERE 19 PATIENTS IN THE BOTULINUM TOXIN AND 22 IN THE NO BOTULINUM TOXIN GROUP. SURGICAL SITE OCCURRENCES (INCLUDING SURGICAL SITE INFECTION, SEROMA FORMATION, AND HEMATOMA FORMATION) WERE SEEN IN 1 NO BOTULINUM TOXIN PATIENT AND 3 BOTULINUM TOXIN PATIENTS AND THE SUBSET OF SUPERFICIAL SURGICAL SITE INFECTIONS WERE SEEN IN 1 PATIENT FROM EACH GROUP. TWO PATIENTS FROM EACH GROUP HAD COMPLICATIONS THAT REQUIRED READMISSION TO THE HOSPITAL. AMONG THEM 2 PATIENTS RETURN TO THE OPERATIVE ROOM. THE FIRST PATIENT REQUIRED TAKE BACK TO THE OPERATIVE ROOM ON POST OPERATIVE DAY 9 AND UNDERWENT A DIAGNOSTIC LAPAROSCOPY DUE TO CONCERNS FOR BOWEL OBSTRUCTION WITH NO EVIDENCE OF HERNIA RECURRENCE. THE SECOND PATIENT WAS TAKEN TO THE OPERATIVE ROOM TWICE, ON POST OPERATIVE DAY 6 FOR DRAINAGE OF ABDOMINAL WALL SEROMA AND SUBSEQUENTLY FOR RECURRENCE OF HERNIA DUE TO LATERAL MESH FAILURE ON POST OPERATIVE DAY 34. IN ADDITION, ACUTE PAIN WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1904062 UNKNOWN PROGRIP MESH PRODUCT Mesh, surgical, polymeric FTL SOFRADIM PRODUCTION SAS UNKNOWN PROGRIP MESH PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H