BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROKERA

    MDR report key: 24621534 · Received March 17, 2026

    Report

    Report Number
    3009809074-2026-00021
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    August 22, 2024
    Report Date
    March 11, 2026
    Manufacturer
    BIOTISSUE HOLDINGS INC.
    Product Code
    NQB
    PMA / PMN Number
    K032104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 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.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNKNOWN INDICATION UTILIZING PROKERA SLIM (PKS). AT A FOLLOW-UP VISIT ON (B)(6) 2024, THE PROKERA WAS REMOVED AND EYELID EDEMA (SWELLING) WAS NOTED. THE PATIENT ALSO NOTED DISCOMFORT, BULBAR REDNESS, AND DIFFICULTY OPENING THE EYE AFTER REMOVAL OF THE PKS. FOUR DAYS LATER, ON (B)(6) 2024, THE SIGNS AND SYMPTOMS RESOLVED WITHOUT FURTHER TREATMENT. HOWEVER, THE PHYSICIAN NOTED MILD CORNEAL EDEMA WHICH WAS SUSPECTED TO BE CAUSED BY A PRE-EXISTING HERPES SIMPLEX VIRUS (HSV) AND THE TREATING PHYSICIAN STARTED THE PATIENT ON ORAL ANTIVIRALS. THE PATIENT WAS DOING BETTER A FEW DAYS LATER AND BACK TO NORMAL BY (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680233 PROKERA PKS NQB BIOTISSUE HOLDINGS INC. PKS SM20230582

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention