BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROKERA

    MDR report key: 11317965 · Received February 11, 2021

    Report

    Report Number
    3009809074-2021-00001
    Event Type
    Injury
    Date Received
    February 11, 2021
    Report Date
    February 4, 2021
    Product Code
    NQB
    PMA / PMN Number
    K032104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED OFF OF THE INFORMATION PROVIDED, THIS EVENT DOES NOT MEET THE CRITERIA FOR A REPORTABLE EVENT. THIS REPORT IS BEING SUBMITTED AS AN ACKNOWLEDGEMENT OF RECEIPT OF THE REPORT FROM ALLERGAN AS WELL AS TO DOCUMENT THE ATTEMPT TO CONTACT THE CUSTOMER FOR ADDITIONAL INFORMATION. SHOULD THE CUSTOMER CONTACT TISSUE TECH, INC. IN THE FUTURE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED RESTASIS EYE DROPS MANUFACTURER, ALLERGAN, TO REPORT VARIOUS ISSUES INCLUDING BACK PAIN, NECK PAIN, AND GRITTY FEELING IN THE EYES. THIS WAS REPORTED VIA MFR REPORT #(B)(4). ALLERGAN PERSONNEL CONTACTED THE PATIENT AND INQUIRED ABOUT PREVIOUS TREATMENTS/MEDICATIONS. AMONG OTHER TREATMENTS AND SURGURIES, THE CUSTOMER STATED THEY WERE PREVIOUSLY TREATED WITH PROKERA, BUT THAT IT HAD TO BE REMOVED AS IT CAUSED THEM PAIN AND HAD FOLDED IN THEIR EYE. NO FURTHER INFORMATION WAS PROVIDED. THE TTI MEDICAL DIRECTOR WAS NOTIFIED OF THE EVENT AND CONTACTED THE CUSTOMER USING THE PHONE NUMBER PROVIDED BY ALLERGAN. THE CUSTOMER DID NOT ANSWER THE PHONE CALL BUT A VOICEMAIL WAS PROVIDED WITH THE MEDICAL DIRECTOR'S CONTACT INFORMATION ON (B)(6) 2021. AS OF 02/04/2021, A RESPONSE HAS NOT BEEN RECEIVED. SHOULD THE CUSTOMER CONTACT THE MD IN THE FUTURE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214696 PROKERA PROKERA NQB

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other LOTEMAX (LOTEPREDNOL ETABONATE)