BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYSORB

    MDR report key: 19355459 · Received May 20, 2024

    Report

    Report Number
    1219930-2024-02208
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    April 17, 2024
    Report Date
    May 20, 2024
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    UDI-DI
    10884521043336
    PMA / PMN Number
    K963253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    NURSE
    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

    ACCORDING TO THE REPORTER, DURING A LOWER SEGMENT CAESAREAN SECTION WITH CONTINUOUS SUTURING TECHNIQUE, THE TIP OF THE NEEDLE BROKE AND FELL INTO THE MAYO STAND TROLLEY. NO DEVICE COMPONENT FELL INTO THE CAVITY OF THE PATIENT. NOTHING WAS DONE AS THE SURGEON FOUND THE TIP OF THE NEEDLE ON THE MAYO STAND. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1570815 POLYSORB SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM COVIDIEN LP LLC NORTH HAVEN CL-915 A9J0987Y 10884521043336

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female