BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIPRO

    MDR report key: 7549285 · Received May 29, 2018

    Report

    Report Number
    1219930-2018-02862
    Event Type
    Injury
    Date Received
    May 29, 2018
    Report Date
    June 3, 2024
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    FTL
    PMA / PMN Number
    K915526
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THIS INFORMATION WAS RECEIVED AS A PART OF AN EXTENSIVE MESH LITIGATION SUBMISSION TO MEDTRONIC. THE FDA WAS NOTIFIED OF THIS LARGE COMPLAINT RECEIPT. DUE TO THE VOLUME OF COMPLAINT INFORMATION RECEIVED BY MEDTRONIC, THIS RESULTED IN A REPORT BEYOND THE 30 DAY TARGET. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    THIS INFORMATION WAS RECEIVED AS A PART OF AN EXTENSIVE MESH LITIGATION SUBMISSION TO MEDTRONIC. THE FDA WAS NOTIFIED OF THIS LARGE COMPLAINT RECEIPT. DUE TO THE VOLUME OF COMPLAINT INFORMATION RECEIVED BY MEDTRONIC, THIS RESULTED IN A REPORT BEYOND THE 30 DAY TARGET. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCARCERATED RIGHT FEMORAL HERNIA REPAIR. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, FISTULA, ADHESIONS, FISTULA, SEROMA, PERFORATION, ABDOMINAL PAIN, INFECTED MESH, FLUID COLLECTION, INFLAMMATION, PURULENT DISCHARGE, PSEUDOMONAS POSITIVE BACTERIAL INFECTION, NONHEALING WOUND, AND EXTENSIVE SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDES CT SCAN, WOUND VAC, DRAINAGE OF INFECTED MESH, REVISION SURGERY AND REMOVAL OF PRIOR MESH.

    Description of Event or Problem · 0

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCARCERATED RIGHT FEMORAL HERNIA REPAIR. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FISTULA, INFECTED MESH, FLUID COLLECTION, INFLAMMATION, PURULENT DISCHARGE, PSEUDOMONAS POSITIVE BACTERIAL INFECTION, NONHEALING WOUND, AND EXTENSIVE SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDES REVISION SURGERY AND REMOVAL OF PRIOR MESH.

    Description of Event or Problem · 0

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCARCERATED RIGHT FEMORAL HERNIA REPAIR. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FISTULA AND INFECTED MESH. THE DEVICE HAD BEEN USED WITH BARD MESH PERFIX PLUG 0112770, L/N 43JLD260. POST-OPERATIVE PATIENT TREATMENT INCLUDES REVISION SURGERY AND REMOVAL OF PRIOR MESH.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. IT WAS REPORTED THAT AFTER A HERNIA PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED SURGICAL REVISION, FISTULA, INFECTED MESH, MESH REMOVAL. THE DEVICE HAD BEEN USED WITH BARD MESH PERFIX PLUG 0112770, L/N 43JLD260. AFTER THE ORIGINAL PROCEDURE, ADDITIONAL POTENTIALLY RELATED PROCEDURES WERE PERFORMED, INCLUDING REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392497 SURGIPRO MESH, SURGICAL, POLYMERIC FTL COVIDIEN LP LLC NORTH HAVEN SPM-35 A2A187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| O BARD MESH PERFIX PLUG 0112770 (LOT# 43JLD260)| UNKNOWN MESH