BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROKERA

    MDR report key: 9885441 · Received March 26, 2020

    Report

    Report Number
    3003415347-2020-00001
    Event Type
    Malfunction
    Date Received
    March 26, 2020
    Date of Event
    January 20, 2020
    Report Date
    March 19, 2020
    Manufacturer
    TISSUE TECH, INC.
    Product Code
    NQB
    PMA / PMN Number
    K032104
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER SERIOUS EVENT WAS SELECTED BASED ON INSTRUCTIONS FROM THE FDA 3500A SUPPLEMENT WHICH STATED FOR MEDICAL DEVICE, WHEN NONE OF THE OTHER OPTIONS APPLIED, SELECT OTHER SERIOUS EVENT. HOWEVER, THIS EVENT DOES NOT MEET THE SERIOUS ADVERSE EVENT DESCRIPTION. THIS REPORT IS BEING SUBMITTED IN RESPONSE TO THE MEDWATCH REPORT MW5092924 RECEIVED FROM THE FDA AND INITIATED BY THE CUSTOMER/HOSPITAL STAFF ON 06FEB2020 .

    Description of Event or Problem · 1

    PATIENT WAS (B)(6) YO MALE WITH VARIOUS CORNEAL ISSUES AND EXPOSURE KERATOPATHY. TREATING PHYSICIAN, DR. (B)(6), DECIDED TO TREAT PATIENT WITH PKCLR AS CORNEAL DEFECT WAS LOCATED INFERIOR CORNEA. PATIENT WAS TREATED WITH A PKCLR. THE PKCLR WAS REMOVED WITH NO ISSUES; PHYSICIAN OBSERVED IMPROVEMENTS IN PATIENT'S CONDITION. PHYSICIAN OPTED FOR 2ND PKCLR TREATMENT DUE TO SUCCESS OF FIRST TREATMENT. PKCLR WAS INSERTED ON (B)(6) 2020 AND REMOVED (B)(6) 2020, WITH NO ABNORMALITIES OBSERVED DURING EXPLANT. DURING FOLLOW-UP WITH THE PATIENT, ABOUT 24 HOURS AFTER EXPLANT, THE PHYSICIAN NOTICED THE SMALL BLUE ELASTIC BAND FROM THE PKCLR ON THE PATIENT'S EYE. THE BAND WAS SUCCESSFULLY REMOVED, AND NO ADVERSE EFFECTS WERE OBSERVED AS A RESULT OF THE ELASTIC BAND STAYING IN THE PATIENT'S EYE. PATIENT WAS DOING WELL AFTER LAST FOLLOW-UP WITH THE PATIENT. THIS INCIDENT WAS INVESTIGATED BY TTI'S MEDICAL DIRECTOR, DR. (B)(6), AND HE CONCLUDED THAT EVEN IN THE WORST-CASE SCENARIO, THIS IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY TO THE EYE BASED ON THE DEVICE DESIGN AND MATERIAL SPECIFICATIONS. IF THIS INCIDENT WERE TO RECUR, INSTEAD, IT WOULD LEAD TO MINOR DISCOMFORT, READILY REVERSIBLE WITH THE REMOVAL OF THE DEVICE. THE BAND AROUND THE DEVICE RING IS A SOFT ELASTIC PIECE WITH NO RIDGES OR SHARP EDGES AND, EVEN THOUGH THE DEVICE UNCLIPPED INSIDE THE PATIENT'S EYE, THE PATIENT DID NOT SUFFER ANY PERMANENT HARM OR DAMAGE AND NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348641 PROKERA PROKERA CLEAR NQB TISSUE TECH, INC. PKCLR BTR180460

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other