BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PROGRIP MESH PRODUCT

    MDR report key: 17962610 · Received October 18, 2023

    Report

    Report Number
    9615742-2023-01393
    Event Type
    Malfunction
    Date Received
    October 18, 2023
    Date of Event
    July 19, 2023
    Report Date
    October 18, 2023
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCT: UNKABSTACK - UNKNOWN ABSORBATACK, LOT# UNKNOWN UNKNOWN-VLOC - UNKNOWN VLOC PRODUCT, LOT# UNKNOWN FORCETRIAD - FORCETRIAD FORCE TRIAD ENERGY PLATFORM, SERIAL# UNKNOWN LITERATURE EVENTS: KRZYSZTOF J. WIKIEL · DANIEL BOLLINGER. PAUL M. MONTERO. TERESA S. JONES. THOMAS N. ROBINSON . EDWARD L. JONES STRAY ENERGY INJURY DURING ROBOTIC VERSUS LAPAROSCOPIC INGUINAL HERNIA REPAIR: A RANDOMIZED CONTROLLED TRIAL KRZYSZTOF J. WIKIEL, 2023, SURGICAL ENDOSCOPY HTTPS://DOI.ORG/10.1007/S00464-023-10331-3 RECEIVED: 13 APRIL 2023 / ACCEPTED: 19 JULY 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. 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 PROSPECTIVE RANDOMIZED CONTROLLED TRIAL EVALUATED THE TRANSFER OF STRAY ENERGY DURING LAPAROSCOPIC VS. ROBOTIC TRANSABDOMINAL PREPERITONEAL (TAPP) INGUINAL HERNIA REPAIR BETWEEN 2019 AND 2022. THE SURGICAL TECHNIQUE INCLUDED PLACEMENT OF AN ANATOMICALLY SIDED PIECE OF PROGRIP MESH, AND THE PERITONEAL FLAP WAS CLOSED USING A 3-0 V LOC OR TACKED WITH ABSORBATAK. THERE WERE 40 PATIENTS INCLUDED IN THE STUDY AND COMPLICATIONS INCLUDED FOUR PATIENTS WITH SEROMA AND THREE PATIENTS WITH PERSISTENT PAIN LASTING GREATER THAN SIX MONTHS. THERE WERE ALSO THREE PATIENTS WITH PAIN LASTING LESS THAN SIX MONTHS. NO CLINICAL MANIFESTATIONS WERE NOTED. ALL PERIOPERATIVE OCCURRENCES RESOLVED WITHOUT INTERVENTION FOR 2 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2078686 UNKNOWN PROGRIP MESH PRODUCT MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN PROGRIP MESH PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown