BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRIP

    MDR report key: 10390471 · Received August 11, 2020

    Report

    Report Number
    9615742-2020-01800
    Event Type
    Injury
    Date Received
    August 11, 2020
    Report Date
    September 5, 2025
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    UDI-DI
    10884521513136
    PMA / PMN Number
    K142900
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO: A4, B5, B6, B7, D8, E1 (STREET 1, CITY, REGION, POSTAL CODE), G1, H6 (PATIENT CODES, IME E2402: LABS ABNORMAL FOR RBC; RDW; AST; BILI DIRECT; CREATININE), <(>&<)> ADDITIONAL CODES. 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

    ADDITIONAL INFO: A4, B5, B7, H6 (PATIENT CODES). 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

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENT HERNIA DUE TO FAILURE OF THE MESH, THE MESH HAD CURLED BACK AND CONTRACTED, LABS ABNORMAL FOR RBC; RDW; AST; BILI DIRECT; CREATININE, <(>&<)> ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION SURGERY, <(>&<)> HERNIA REPAIR WITH 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 A BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN, DISCOMFORT, DEFECTIVE MESH, RECURRENT HERNIA DUE TO FAILURE OF THE MESH, THE MESH HAD CURLED BACK AND CONTRACTED, LABS ABNORMAL FOR RBC; RDW; AST; BILI DIRECT; CREATININE, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION SURGERY, AND HERNIA REPAIR WITH MESH.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: (LOT# RSC1028X). 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 OF A HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENT HERNIA DUE TO FAILURE OF THE MESH AND THE MESH HAD CURLED BACK AND CONTRACTED. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855254 PROGRIP MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS LPG1510 PSC1426X 10884521513136

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| S LPG1510 10 X 15 CM LP PROGRIP FLATSHEET MSH| LPG1510 10X15CM LP PROGRIP FLATSHEETMSH