BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGITIE

    MDR report key: 24782166 · Received April 3, 2026

    Report

    Report Number
    9612501-2026-00983
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 30, 2026
    Report Date
    April 3, 2026
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAL
    UDI-DI
    10884521099630
    PMA / PMN Number
    K904588
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: EL-21-L, EL-21-L POLYSORB* 0 VIO 52CM TIE WDX6 (LOT # J5J4174Y). 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 REPORTER, DURING THE APPENDECTOMY, WHEN SUTURING THE APPENDIX, THE TWO SUTURES BROKE ON THE CENTER REGION. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844205 SURGITIE SUTURE, ABSORBABLE, NATURAL GAL DAVIS & GECK CARIBE LTD EL-21-L J5J4174Y 10884521099630

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11