BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROKERA

    MDR report key: 24608181 · Received March 16, 2026

    Report

    Report Number
    3009809074-2026-00024
    Event Type
    Injury
    Date Received
    March 16, 2026
    Report Date
    March 13, 2026
    Manufacturer
    BIOTISSUE HOLDINGS INC.
    Product Code
    NQB
    PMA / PMN Number
    K032104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 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 18FEB2026 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 18FEB2026.

    Description of Event or Problem · 0

    PROKERA SLIM WAS PLACED ON THE EYE OF A PATIENT FOR 3 DAYS AND UPON REMOVAL WAS NOTED TO HAVE SIGNIFICANT OCULAR INFLAMMATION. PATIENT HAD 4+ INJECTION (OCULAR REDNESS), SIGNIFICANT SUPERFICIAL PUNCTATE KERATITIS (SPK), CORNEAL STROMAL EDEMA, WITHOUT IRITIS. NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED ON TREATMENT PROVIDED FOR THE COMPLAINTS, NOR FOR THE PATIENT'S PRE-EXISTING CONDITION(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665373 PROKERA PROKERA SLIM NQB BIOTISSUE HOLDINGS INC. PKS SM20230759

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention