MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD MILTEX BIOPBLADE 50 PER BOX; M3 - DERMAL

Catalog Number	33-100
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported that the staff member was cut by the miltex biopblade 50 per box (33-100), as she was pulling the product out of the box to set up for a procedure.The blade sliced through the paper wrapping that it was packaged in.There was a small laceration to tip of the left thumb, that required first aid only medical treatment provided on site.The staff condition is normal and there were no surgical delay reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated field: d9, g3, g6, h2, h3, h6, h11.The miltex biopblade (b)(4) per box (33-100) was not returned for evaluation: the device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.The miltex biopblade (b)(4) per box (33-100) was not returned for evaluation after three good faith attempts (gfes) were made.Supplier investigation found no quality or manufacturing issues related to the production of the product.The supplier change order is underway to change the product packaging to blister packs.The definite root cause of the reported issue could not be determined.Product packaging changes to blister packs are underway under the supplier change order.If additional relevant information becomes available in the future, this complaint will be reopened and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: MILTEX BIOPBLADE 50 PER BOX
• Common Device Name: M3 - DERMAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 23679776
• Report Number: 3014334038-2025-00146
• Device Sequence Number: 21257546
• Product Code: GDX
• UDI-Device Identifier: 10381780064312
• UDI-Public: 10381780064312
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 01/02/2026

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 Catalogue Number: 33-100
• Device Lot Number: 23J04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2023
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White