BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LABORIE INJETAK ADJUSTABLE TIP NEEDLE

    MDR report key: 16461626 · Received February 28, 2023

    Report

    Report Number
    MW5115327
    Event Type
    Injury
    Date Received
    February 28, 2023
    Date of Event
    February 20, 2023
    Report Date
    February 24, 2023
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES CORP.
    Product Code
    FBK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RECALLED BOTOX NEEDLE USED DURING SURGICAL CASE ON (B)(6) 2023. EMAIL SENT TO THE CHARGE RN 2/21/2023. NO COMMUNICATION OF RECALL PRIOR TO THIS EMAIL. AS OF 2/23/2023, PATIENT HAD NO SIGN OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912935 LABORIE INJETAK ADJUSTABLE TIP NEEDLE ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY FBK LABORIE MEDICAL TECHNOLOGIES CORP. D228088

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female