BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX

    MDR report key: 20905940 · Received December 11, 2024

    Report

    Report Number
    9615742-2024-01682
    Event Type
    Injury
    Date Received
    December 11, 2024
    Date of Event
    March 6, 2024
    Report Date
    December 11, 2024
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    UDI-DI
    10884521165724
    PMA / PMN Number
    K142908
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCES: SUCCESSFUL NON-OPERATIVE MESH SALVAGE USING A MULTI-MODAL TREATMENT STRATEGY FOR INFECTED COMPOSITE MESH AMY AIMEI JIANG, JOEL LAU, WEI KEAT CHEAH, MAN HON TANG YEAR:2024, THE AUTHOR(S) DOI.ORG/10.1007/S10029-024-03017-9. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, AN OBESE 60-YEAR-OLD GENTLEMAN UNDERWENT EMERGENCY SURGERY FOR PORT SITE HERNIA AND BOWEL OBSTRUCTION, WHICH DEVELOPED THREE DAYS FOLLOWING LAPAROSCOPIC SMALL BOWEL RESECTION. A COMPOSITE VENTRAL PATCH 8.6 CM WAS PLACED IN THE INTRA-PERITONEAL LAYER DUE TO A 4 CM FASCIAL DEFECT. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH PAIN, FEVER, AND ABNORMAL LABORATORY VALUES AND UNDERWENT COMPUTED TOMOGRAPHY (CT), WHICH SHOWED AN EXTENSIVE INFECTION SURROUNDING THE MESH. URGENT PERCUTANEOUS DRAINAGE AND INTRAVENOUS ANTIBIOTICS WERE REQUIRED, FOLLOWED BY DILUTION AND WASHOUT OF THE CAVITY WITH LARGE VOLUMES OF SALINE SOLUTION. A CT SCAN PERFORMED AT THE END OF THE TREATMENT CONFIRMED RESOLUTION OF THE INFECTION, AND THE PATIENT REMAINED WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1731355 PARIETEX MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS PCO8VP 10884521165724

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention