BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN TICRON

    MDR report key: 24757593 · Received April 1, 2026

    Report

    Report Number
    9612501-2026-00951
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Report Date
    April 1, 2026
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PARAESOPHAGEAL HERNIA (PEH) PROCEDURE, THE SUTURE WAS PERCEIVED AS HARDER TO PASS THROUGH TISSUE AND ROUGHER. ANOTHER SUTURE FROM OTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816066 UNKNOWN TICRON SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT DAVIS & GECK CARIBE LTD UNKNOWN TICRON

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown