MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OMNIGRAFT DERMAL REGENERATION MATRIX 2.5CM X 2.5CM; INTEGRA OMNIGRAFT DERMAL REGENERATION MATRIX

Model Number	DFU25251
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Omnigraft dermal (dfu25251) was not returned for evaluation.Device history record (dhr) review - no anomalies found.The label for lot 5329553 is applicable to the product packaging, while the label for lot 4742283 is applicable to the omnigraft device.Omnigraft expiration date is 36 months from the month of packaging (the first day the material was packaged into the primary packaging) which for this lot was 11jun2020.It is confirmed that the lowest expiration date was used from the component items to obtain the overall device lot number: 30jun2023.Use of the earliest expiration date is a conservative approach taken to ensure the entire contents do not get used past the earliest expiration date of any of the finished good¿s components.The product was within its expiry at the time of patient contact on 10nov2021.Failure analysis - the investigation confirms that there is no basis to the complaint.The presence of the labels was appropriate and that the expiration dates and lot numbers were correct.Root cause - the complaint was predicated on the complainant¿s concern over the product¿s dissimilar lot numbers and expiration date.This investigation confirmed that the presence of those labels was appropriate and that the expiration dates printed on them were correct.Therefore, there is no root cause to determine as there is no basis to the complaint.
Event or Problem Description
Medwatch report number: (b)(4).A facility reported that the outer package of the omnigraft dermal (dfu25251) has different lot number and expiration date than the inner package.Outer expiration: 2022-01-05; while inner expiration: 2023-06-30.

• Brand Name: OMNIGRAFT DERMAL REGENERATION MATRIX 2.5CM X 2.5CM
• Common Device Name: INTEGRA OMNIGRAFT DERMAL REGENERATION MATRIX
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; 105 morgan lane; plainsboro NJ
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; plainsboro NJ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13722107
• Report Number: 1121308-2022-00012
• Device Sequence Number: 14608363
• Product Code: MDD
• UDI-Device Identifier: 10381780258872
• UDI-Public: 10381780258872
• Combination Product (Y/N): N
• PMA/510(K) Number: P900033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2022

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 Model Number: DFU25251
• Device Catalogue Number: DFU25251
• Device Lot Number: 5329553, 442283
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 03/10/2022
• 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: 52 YR
• Patient Sex: Unknown