BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CBSU MICROKERATOME

    MDR report key: 11901176 · Received May 28, 2021

    Report

    Report Number
    9615659-2021-00005
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    April 23, 2021
    Report Date
    May 28, 2021
    Product Code
    HMY
    PMA / PMN Number
    K981741
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    HEALTHCARE PROVIDER REPORTED PARTIAL FLAP DURING LASIK SURGERY. HEALTHCARE PROVIDER SENT IN DISPOSABLE CBSU HEAD, CB TURBINE AND (4) O-RINGS FOR EVALUATION. ALSO, SENT IN SURGICAL DATA (FLAP COMPLICATION REPORT AND PATIENT TREATMENT PLAN) FOR EVALUATION. PRK SCHEDULED FOR A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798358 CBSU MICROKERATOME CBSU MICROKERATOME HMY 19312/130 2192101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CB 0-RING REF. 19309/0| CB TURBINE REF. 19303