BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSYN

    MDR report key: 21602850 · Received March 14, 2025

    Report

    Report Number
    9612501-2025-00761
    Event Type
    Malfunction
    Date Received
    March 14, 2025
    Date of Event
    February 21, 2025
    Report Date
    March 14, 2025
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAM
    UDI-DI
    10884521033269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: SM822, SM-822 BIOSYN 3-0 UND 75CM C13 X36, (LOT#D2J1841FY); SM822, SM-822 BIOSYN3-0 UND 75CM C13 X36, (LOT#D2J1841FY); SM822, SM-822 BIOSYN 3-0 UND 75CM C13 X36, (LOT#D2J1841FY); SM822, SM-822 BIOSYN 3-0 UND 75CM C13 X36, (LOT#D2J1841FY) 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 THE AT THE TIME OF SUTURING ON A PLASTIC SURGERY, SEVERAL THREADS OF BIOSYN 3/0 SM-822 WERE USED AND SUDDENLY CAME LOOSE DURING THE SUTURE LEAVING THE NEEDLE IN THE SKIN. FOUR OTHER THREADS USED WITH THE NEEDLE REMAINED STUCK IN THE PATIENT'S SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2090089 BIOSYN SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM DAVIS & GECK CARIBE LTD SM822 D2J1841FY 10884521033269

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11