TCC-EZ® TCC23002Recalls & reported problems
Acell, Inc. · TCC-EZ® Single Kit · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00809958005316), received between Jan 3, 2025 and Mar 14, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Material Too Soft/Flexible” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Too Soft/Flexible3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 14, 2025Material Too Soft/Flexible; Material Too Soft/Flexible
THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3005920706-2025-00008. A NURSE REPORTED THAT A TCC CAST (UNKNOWN ID) DID NOT SET COMPLETELY WHEN APPLIED, LEAVING THE ACHILLIES/ANKLE/MALLEOLUS LOOSE AND THE ANKLE/FOOT LARGELY UNSECURED BY THE CAST SO IT IS ¿SOFT¿. THE RECOMMENDED WATER TEMPERATURE WAS FOLLOWED. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21606859 ↗MalfunctionMar 14, 2025Material Too Soft/Flexible; Material Too Soft/Flexible
THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3005920706-2025-00009. A NURSE REPORTED THAT A TCC CAST (UNKNOWN ID) DID NOT SET COMPLETELY WHEN APPLIED, LEAVING THE ACHILLIES/ANKLE/MALLEOLUS LOOSE AND THE ANKLE/FOOT LARGELY UNSECURED BY THE CAST SO IT IS "SOFT". THE RECOMMENDED WATER TEMPERATURE WAS FOLLOWED. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21606858 ↗InjuryJan 3, 2025Material Too Soft/Flexible; Material Too Soft/Flexible
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.
Patient problems: Insufficient Information
MAUDE report 21067077 ↗
Other BANDAGE, CAST devices
- DeRoyal 30-321Deroyal Industries, Inc. · BANDAGE, CAST1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.