BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PROGRIP MESH PRODUCT

    MDR report key: 21104261 · Received January 8, 2025

    Report

    Report Number
    9615742-2025-00019
    Event Type
    Injury
    Date Received
    January 8, 2025
    Date of Event
    September 27, 2024
    Report Date
    January 8, 2025
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: UNKNOWN-VLOC, UNKNOWN VLOC PRODUCT (SERIAL#:UNK) (LOT#:UNK) (B)(6). "REDUCED RISK OF RECURRENCE FOLLOWING ROBOTIC-ASSISTED TAPP FOR INGUINAL HERNIA REPAIR COMPARED TO LAPAROSCOPIC TAPP: A COHORT STUDY OF 395 CASES", 2024, HERNIA (2025) 29:33 HTTPS://DOI.ORG/10.1007/S10029-024-03226-2. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY WAS CONDUCTED BETWEEN 2017 AND 2019 INVOLVING 395 CASES OF LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL (TAPP) PROCEDURE OR ROBOTIC-ASSISTED TAPP (R-TAPP) FOR INGUINAL HERNIA REPAIR. THE SELF-FIXATING MESH WAS USED IN THE R-TAPP PROCEDURE AND THE PERITONEUM WAS CLOSED USING A 2-0 V-LOC SUTURE. BRANDED MESH, FIXATION DEVICES, OR SUTURE WERE NOT MENTIONED IN THE TAPP PROCEDURE DESCRIPTION. COMPLICATIONS IN BOTH GROUPS INCLUDE HEMATOMA AND HERNIA RECURRENCE. NO INTERVENTIONS ARE MENTIONED. OTHER NON-DEVICE RELATED COMPLICATIONS INCLUDED CHRONIC PAIN AND WOUND INFECTIONS. ARTICLE: MICHAEL FESTERSEN NIELSEN, HERNIA (2025) 29:33 HTTPS://DOI.ORG/10.1007/S10029-024-03226-2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882783 UNKNOWN PROGRIP MESH PRODUCT MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN PROGRIP MESH PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O SEE H11