BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNAL NEEDLE DOUBLE WIRE BALL.CS#3.USP#6.65MM

    MDR report key: 14194443 · Received April 22, 2022

    Report

    Report Number
    MW5109307
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    April 8, 2022
    Report Date
    April 20, 2022
    Manufacturer
    AE MEDICAL / ALTO DEVELOPMENT CORP.
    Product Code
    GAO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ONE STERNAL NEEDLE (REF. 046-297 AE MEDICAL) GOT BROKE AND HALF OF IT STUCK IN THE STERNUM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445367 STERNAL NEEDLE DOUBLE WIRE BALL.CS#3.USP#6.65MM SUTURE, NONABSORBABLE GAO AE MEDICAL / ALTO DEVELOPMENT CORP. 046-297

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male