BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CBSU MICROKERATOME

    MDR report key: 11624334 · Received April 6, 2021

    Report

    Report Number
    9615659-2021-00003
    Event Type
    Injury
    Date Received
    April 6, 2021
    Date of Event
    March 4, 2021
    Report Date
    April 6, 2021
    Product Code
    HMY
    PMA / PMN Number
    K981741
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    HEALTHCARE PROVIDER REPORTED THAT PATIENT HAD DLK ON (B)(6) 2021 (HAD TWO OTHER SIMILAR INCIDENTS RECENTLY). HEALTHCARE PROVIDER WILL SEND IN (2) UNUSED CB DISPOSABLE HEADS, (2) CB TURBINES & (2) CB RING SETS FOR EVALUATION; THE DISPOSABLE HEADS LOT 2190303 INVOLVED IN THE SURGERY WERE NOT SAVED. HEALTHCARE PROVIDER WILL DISCARD (NON-MORIA) CANNULAS USED IN SURGERY AND PURCHASE NEW CANNULAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521636 CBSU MICROKERATOME CBSU MICROKERATOME HMY 19312/110 2190303

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention