BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROKERA

    MDR report key: 12099351 · Received July 1, 2021

    Report

    Report Number
    3009809074-2021-00004
    Event Type
    Injury
    Date Received
    July 1, 2021
    Date of Event
    May 28, 2021
    Report Date
    June 29, 2021
    Product Code
    NQB
    PMA / PMN Number
    K032104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRODUCT ISSUE FORM SUBMITTED FOR (B)(4) INDICATED A PATIENT WAS TREATED WITH PROKERA AND EXPERIENCED A STINGING SENSATION AND SPK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994740 PROKERA PROKERA SLIM NQB BTR193558

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention