BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITIE

    MDR report key: 19117676 · Received April 16, 2024

    Report

    Report Number
    9612501-2024-00983
    Event Type
    Injury
    Date Received
    April 16, 2024
    Date of Event
    February 20, 2024
    Report Date
    June 12, 2024
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAL
    UDI-DI
    10884521099630
    PMA / PMN Number
    K904588
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: EL-21-L - EL-21-L POLYSORB* 0 VIO 52CM TIE WDX6, LOT# J3G2671Y EL-21-L - EL-21-L POLYSORB* 0 VIO 52CM TIE WDX6, LOT# J3G2671Y 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, 2 DAYS POSTOPERATIVELY, OF AN LAPAROSCOPIC APPENDECTOMY PROCEDURE, WHEN THE DEVICE USED TO CLOSE THE APPENDIX, THERE WAS A RELEASE OR THE LOOPS LOOSENED FOR THE THREE SYNTHETIC LIGATURE LOOPS DUE TO THE APPENDECTOMY, WHICH RESULTED IN PERITONITIS. IT WAS NOTED THAT IT WAS VERY PAINFUL FOR THE PATIENT. TO RESOLVE THE ISSUE, ADDITIONAL SURGERY FOR CLOSURE OF THE APPENDICULAR STUMP WAS DONE BY STAPLING.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, POSTOPERATIVELY, OF AN LAPAROSCOPIC APPENDECTOMY PROCEDURE, WHEN THE DEVICE USED TO CLOSE THE APPENDIX, T HERE WAS A RELEASE OR THE LOOPS LOOSENED FOR THE THREE SYNTHETIC LIGATURE LOOPS DUE TO THE APPENDECTOMY, WHICH RESULTED IN PERITONITIS. IT WAS NOTED THAT IT WAS VERY PAINFUL FOR THE PATIENT. TO RESOLVE THE ISSUE, ADDITIONAL SURGERY FOR CLOSURE OF THE APPENDICULAR STUMP WAS DONE BY STAPLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333731 SURGITIE SUTURE, ABSORBABLE, NATURAL GAL DAVIS & GECK CARIBE LTD EL-21-L J3G2671Y 10884521099630

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R SEE H11