MAUDE Adverse Event Report: DERMA SCIENCES, INC. TCC-EZ UNKNOWN

Catalog Number	XXX-TCC-EZ
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
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 a tcc cast (id (b)(6)) was drying with wrinkles when smooth upon application.They felt the resin was not distributed evenly throughout the material.The patients are leaving the facility after the recommended drying time with the cast smooth.They report the wrinkles are noticeable.A new wound created in one patient at the wrinkles site.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The tcc cast (id (b)(4)) was not returned for evaluation but a photo was provided: dhr - no capa or nc record was found related to this product.Failure analysis - additional subject matter experts in the area of tcc cast application and device functionality were present and reviewed the photos provided within this complaint.Upon discussion with them, it was determined that this complaint is a clear example of user error with the photos shown displaying casting systems in both cases that are applied incorrectly, either with the casting sock not being set at a proper angle, or the casting unit not being applied correctly of folded improperly multiple ways.Root cause - given the review of evidence provided by suject matter experts, the failure family is determined to be user error - improper use of device.

• Brand Name: TCC-EZ UNKNOWN
• Common Device Name: TCC-EZ
• Manufacturer (Section D): DERMA SCIENCES, INC.; 104 shorting road; 104 shorting road; toronto, ontario M1S 3 S4; CA M1S 3S4
• Manufacturer (Section G): DERMA SCIENCES, INC.; 104 shorting road; toronto, ontario M1S 3 S4; CA M1S 3S4
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21067077
• Report Number: 3005920706-2024-00022
• Device Sequence Number: 12861749
• Product Code: ITG
• UDI-Device Identifier: 00809958005316
• UDI-Public: 00809958005316
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: XXX-TCC-EZ
• Device Lot Number: 1024009
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown