BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPICEL

    MDR report key: 23486004 · Received November 6, 2025

    Report

    Report Number
    3002836339-2025-00078
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    August 15, 2025
    Report Date
    November 6, 2025
    Manufacturer
    VERICEL
    Product Code
    OCE
    PMA / PMN Number
    990200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOTE REGARDING H1 (MANDATES) FIELD: THE ESUBMITTER SYSTEM REQUIRES A SELECTION IN FIELD H1. ALTHOUGH THIS SUBMISSION IS PART OF A ROUTINE PERIODIC SAFETY REPORT AND NO FDA-MANDATED REPORTING REQUIREMENT IS SPECIFICALLY APPLICABLE, THE FIELD WAS POPULATED WITH "SERIOUS INJURY"" SOLELY TO SATISFY SYSTEM VALIDATION REQUIREMENTS. CASE REFERENCE NUMBER (B)(4) (INITIAL) IS A SPONTANEOUS REPORT INITIALLY RECEIVED FROM A COMPANY EMPLOYEE ON 15-AUG-2025, CONCERNING A 22-YEAR-OLD FEMALE PATIENT WHO RECEIVED EPICEL GRAFTS. HOWEVER, 9 DEFECTIVE GRAFTS WERE COMPLETELY DETACHED FROM GAUZE BACKING AND FLOATING IN MEDIUM (PT: PRODUCT QUALITY ISSUE). ON 15-AUG-2025, UPON OPENING CARTRIDGES IN THE OPERATION ROOM (OR), 9 GRAFTS WERE NOTED TO BE COMPLETELY DETACHED FORM GAUZE BACKING AND FLOATING IN MEDIA (PT: PRODUCT QUALITY ISSUE). SEVERAL OF THE BACKINGS WERE FLOATING IN MEDIA AND WERE NOT ATTACHED TO THE CARTRIDGE. THE GRAFTS WERE DISPOSED OF IN THE BIOHAZARD CONTAINER. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATION DETAILS WERE NOT REPORTED. ON (B)(6) 2025, THE PATIENT RECEIVED 70 EPICEL GRAFTS (CULTURED EPIDERMAL AUTOGRAFTS, LOT NUMBER: EE03506-33, EXPIRATION DATE:15-AUG-2025, UDI: (B)(4) FOR THERMAL BURN. NO ADVERSE EVENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED. COMPANY COMMENT: VERICEL ASSESSED THE EVENT OF PRODUCT QUALITY ISSUE AS NON-SERIOUS, POSSIBLY RELATED AND EXPECTED. THE CASE DOES NOT QUALIFY AS AN MDR, NOR AS A 15-DAY REPORT.

    Description of Event or Problem · 0

    9 DEFECTIVE GRAFTS/ COMPLETELY DETACHED FROM GAUZE BACKING AND FLOATING IN MEDIUM [PRODUCT QUALITY ISSUE].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2688331 EPICEL CULTURED EPIDERMAL AUTOGRAFTS OCE VERICEL EE03506-33

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female