BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROKERA

    MDR report key: 24626460 · Received March 18, 2026

    Report

    Report Number
    3009809074-2026-00015
    Event Type
    Injury
    Date Received
    March 18, 2026
    Date of Event
    November 2, 2025
    Report Date
    March 12, 2025
    Manufacturer
    BIOTISSUE HOLDINGS INC.
    Product Code
    NQB
    PMA / PMN Number
    K032104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE COVER LETTER IN ATTACHMENTS RE: RETROSPECTIVE SUBMISSION OF MEDICAL DEVICE REPORTS (MDRS) FOLLOWING BIOTISSUE HOLDINGS INC. FDA INSPECTION CONCLUDING ON 02/18/2026 (FEI # (B)(4)). THE ATTACHED MEDICAL DEVICE REPORT, IS BEING SUBMITTED AS PART OF THE ACTIONS TAKEN BY BIOTISSUE HOLDINGS INC. (BTHI), IN RESPONSE TO FDA INVESTIGATOR FEEDBACK AND A 483 OBSERVATION RECEIVED 02/18/2026, REGARDING NOT SUBMITTING MDR REPORT WITHIN 30 DAYS OF BEING AWARE OF INFORMATION, THAT REASONABLY SUGGESTED THAT A MARKETED DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO DEATH OR SERIOUS INJURY. DURING THE INSPECTION, FEEDBACK AND ADDITIONAL INFORMATION WERE PROVIDED REGARDING THE NEED TO INITIATE MDRS FOR ADVERSE EVENT CASES WHERE ANY MEDICAL OR SURGICAL TREATMENT WAS PROVIDED EVEN WHEN THE CAUSAL RELATIONSHIP TO THE DEVICE IS NOT EVIDENT, EVEN WHEN THE ADVERSE EVENT IS SELF-LIMITED, AND EVEN WHEN SUCH EVENTS MAY ARISE FROM UNDERLYING PATIENT CONDITIONS RATHER THAN DEVICE MALFUNCTION OR PERFORMANCE CONCERNS. THE FEEDBACK RECEIVED EXPANDED THE REPORTABILITY CRITERION BTHI WAS FOLLOWING BASED ON 21 CFR 803 REGULATION. AS BTHI IS FULLY COMMITTED TO COMPLIANCE WITH FDA REPORTING REQUIREMENTS, A RETROSPECTIVE REVIEW OF ADVERSE EVENTS SINCE THE LAST INSPECTION (MAR 2024) WAS COMPLETED. IN THIS LOOK BACK, ADVERSE EVENT CASES ALREADY INVESTIGATED AND DETERMINED NOT REPORTABLE WERE REASSESSED PER THE EXPANDED CRITERIA PROVIDED DURING THE INSPECTION THAT REDEFINED AS REPORTABLE CASES WHERE MEDICAL OR SURGICAL TREATMENT WAS PROVIDED, REGARDLESS OF CLINICAL OUTCOME OR RELATIONSHIP TO DEVICE PERFORMANCE. THE REVIEW IDENTIFIED ADVERSE EVENTS INVESTIGATED BETWEEN MARCH 2024 AND FEBRUARY 2026 THAT, UPON REASSESSMENT, MET THE EXPANDED CRITERIA FOR REPORTABILITY. THIS MDR SUBMISSION DATE FALLS OUTSIDE THE STANDARD 30 DAY REPORTING REQUIREMENT FROM THE AWARENESS DATE OF THE ADVERSE EVENTS. AS THEY WERE IDENTIFIED REPORTABLE PER THE EXPANDED SCOPE AND CRITERIA RECEIVED POST-INSPECTION 02/18/2026. WE RESPECTFULLY REQUEST THAT FDA ACCEPT THIS RETROSPECTIVE MDR AS PART OF OUR COMMITMENT TO ADDRESS THE OBSERVATION, PERFORM CORRECTIVE ACTION, ENHANCE REGULATORY COMPLIANCE, AND CONTINUOUS IMPROVEMENT.

    Description of Event or Problem · 0

    ON (B)(6) 2025, THE PATIENT HAD A PROKERA SLIM DEVICE PLACED ONTO THE EYE FOR TREATMENT OF PERSISTENT EYE SCRATCHINESS AND PAIN. TOPICAL ANESTHETIC WAS APPLIED PRIOR TO INSERTION. FOLLOWING PLACEMENT, A NICTAVI EYE PATCH WAS APPLIED OVER THE EYELID TO MINIMIZE DEVICE MOVEMENT. AT THE REQUEST OF THE PATIENT'S DAUGHTER, A PRESSURE PATCH WAS ALSO PLACED OVER THE NICTAVI PATCH TO PREVENT THE PATIENT FROM TOUCHING THE EYE. ON (B)(6) 2025, THE PATIENT RETURNED TO CLINIC DUE TO PAIN AND DISCOMFORT, EYELID INFLAMMATION AND SWELLING. THE DEVICE WAS REMOVED ONE DAY EARLIER THAN THE PLANNED REMOVAL DATE. AFTER REMOVAL, EXAMINATION OF THE EYE NOTED THAT THE CORNEA AND CONJUNCTIVA "LOOKED GREAT." THERE WAS NO IMPACT TO THE PATIENT'S VISION. THE PATIENT WAS GIVEN A SMALL SAMPLE OF LOTEMAX (STEROID), TO BE APPLIED 2X DAILY AND INSTRUCTED TO APPLY A COLD COMPRESS TO THE AFFECTED AREA. THE PATIENT WAS REPORTED TO BE RESOLVING. THE DOCTOR ATTRIBUTES THE INFLAMMATION AND SWELLING OF THE EYELID, TO BE A RESULT OF AN ALLERGY OR IRRITATION TO THE ADHESIVE OF THE NICTAVI PATCH, AS WELL AS THE INCREASED TAPING AND MOVEMENT (PATIENT WENT OUT DURING WEAR PERIOD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689714 PROKERA PROKERA SLIM NQB BIOTISSUE HOLDINGS INC. PKS TGJB25K011

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Required Intervention EYE PRESSURE PATCH| NICTAVI TARSUS EYELID PATCH| PROPARACAINE (TOPICAL ANESTHETIC)