MAUDE Adverse Event Report: VERICEL EPICEL; CULTURED EPIDERMAL AUTOGRAFTS

Lot Number	EE03352
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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) is a spontaneous report *initially* received from a company employee, on 21-jan-2025, concerning a 11-year-old female patient scheduled to have grafts implanted.However, 12 grafts were runny and unusable due to the cells sliding off the backing with the consistency of snot (pt: product quality issue).On 19-jan-2025, qc lot release assays (graft inspection qc2-027, dual stain qc2-094, endotoxin qc2-010, sterility pre-release qc2-005, sterility final product qc2-012) and environmental results (manufacturing: grade a (fingertips - left and right, bsc hood surface, settling plate - left and right, sleeve - left and right) and grade b (viable air particulates and nonviable air particulates) and qc sterility: grade a (fingertips - left and right, bsc hood surface, settling plate - left and right, sleeve - left and right)) were performed.All results were reported as ''pass''.Qc lot release assay (implemented 29-sep-2019) 3t3 residual assay q2c-136 was reported as 0.25 - pass.* the patient's medical history and concomitant medication details were not reported.On 21-jan-2025, 35 grafts were sent with additional ten grafts included.Twelve of 45 epicel grafts were runny and unusable due to the cells sliding off the backing with the consistency of snot (pt: product quality issue).The backings were noted to be intact with all clips in place and secured.There was no reported damage to the foil or epicel container, nor the shipping container.In addition, there was no evidence of media leak from these packages.It was confirmed that the detached grafts were in a consecutive order in the shipping container.On the same date, the patient received 33 unaffected epicel grafts (cultured epidermal autografts, lot number: *ee03352*, expiration date: 21-jan-2025) for thermal burn.The 12 affected grafts were unusable and were discarded by surgeon.No adverse event was reported.Additional information was received on 22-jan-2025, 23-jan-2025 and 27-jan-2025 and processed with the initial.No further information was provided.All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).Follow-up information was received from the reporter on 12-feb-2025 and included qc results, the additional reporter and the lot number for epicel was updated.Company comment: vericel has assessed a product quality issue as non-serious, possibly related and expected.The case does not qualify as an mdr, nor as a 15-day-report.
Event or Problem Description
12 grafts were runny and unusable due to the cells sliding off the backing with the consistency of snot [product quality issue].

• Brand Name: EPICEL
• Common Device Name: CULTURED EPIDERMAL AUTOGRAFTS
• Manufacturer (Section D): VERICEL; 64 sydney st; cambridge MA 02139
• Manufacturer (Section G): VERICEL; 64 sydney st; cambridge MA 02139
• Manufacturer Contact: 64 sydney st; cambridge, MA 02139
• MDR Report Key: 23494538
• Report Number: 3002836339-2025-00019
• Device Sequence Number: 9037880
• Product Code: OCE
• UDI-Device Identifier: W41020AU201S1969
• UDI-Public: W41020AU201S1969
• Combination Product (Y/N): Y
• PMA/510(K) Number: 990200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/21/2025
• Device Lot Number: EE03352
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 11/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Sex: Female