BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROKERA

    MDR report key: 24626492 · Received March 18, 2026

    Report

    Report Number
    3009809074-2026-00017
    Event Type
    Injury
    Date Received
    March 18, 2026
    Date of Event
    August 20, 2024
    Report Date
    March 12, 2026
    Manufacturer
    BIOTISSUE HOLDINGS INC.
    Product Code
    NQB
    PMA / PMN Number
    K032104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    PHYSICIAN REPORTED THEY HAD A PATIENT DEVELOP A CORNEAL ULCER AFTER A PROKERA SLIM INSERTION. PATIENT'S EYE HAD A PRE-EXISTING NEUROTROPHIC PERSISTENT EPITHELIAL DEFECT INVOLVING THE INFERIOR CORNEA. PROKERA SLIM WAS APPLIED TO THE EYE. THE DOCTOR DID NOT CHECK THE CENTRATION OF THE PROKERA SLIM AFTER INSERTION NOR WAS TAPE TARSORRHAPHY APPLIED TO ADDRESS OCULAR EXPOSURE ISSUES. PROKERA SLIM WAS REMOVED AFTER 1 DAY OF APPLICATION BECAUSE THE PATIENT COMPLAINED OF SERIOUS PAIN. THE NEXT DAY, THE PATIENT CAME IN AND THE PHYSICIAN IDENTIFIED A CORNEAL ULCER. THE PHYSICIAN NOTED HE PRESUMED THIS TO BE AN INFECTIOUS CORNEAL ULCER (INFECTIOUS KERATITIS), BUT NO CORNEAL CULTURE OR SCRAPINGS WERE TAKEN TO CONFIRM. THE PATIENT UNDERWENT A CORNEAL TRANSPLANT AND RECOVERED WITH 20/40 VISUAL ACUITY (INITIAL VISUAL ACUITY WAS NOT REPORTED). THE MANUFACTURER INTERNAL REFERENCE NUMBER FOR THIS EVENT IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691812 PROKERA PROKERA SLIM NQB BIOTISSUE HOLDINGS INC. PKS SM20230454

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention