BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROKERA

    MDR report key: 16876801 · Received May 4, 2023

    Report

    Report Number
    MW5117251
    Event Type
    Malfunction
    Date Received
    May 4, 2023
    Report Date
    May 1, 2023
    Manufacturer
    BIOTISSUE HOLDINGS INC.
    Product Code
    NQB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT TRIED AND FAILED - NOT ASSISTING WITH SYMPTOMS. PAE REPORTED BY HCP, WHO DOES NOT CONSENT TO FOLLOW UP. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817916 PROKERA CONFORMER, OPHTHALMIC, BIOLOGICAL TISSUE NQB BIOTISSUE HOLDINGS INC. AE-32805

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown