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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bandage, cast
Regulation Description Prosthetic and orthotic accessory.
Product CodeITG
Regulation Number 890.3025
Device Class 1

MDR Year MDR Reports MDR Events
2021 6 6
2022 9 9
2023 3 3
2024 8 8
2025 4 4
2026 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Material Too Soft/Flexible 17 17
Crack 3 3
Material Integrity Problem 3 3
Insufficient Device Problem Information 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Product Quality Problem 2 2
Mechanical Problem 1 1
Failure to Obtain Sample 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18 18
Insufficient Information 3 3
Unspecified Tissue Injury 3 3
Partial thickness (Second Degree) Burn 3 3
Skin Infection 2 2
Unspecified Skin and Subcutaneous Tissue Problem 2 2
Skin Inflammation/ Irritation 2 2
Inflammation 2 2
Blister 2 2
Unspecified Infection 1 1
Hypersensitivity/Allergic reaction 1 1
Skin Disorders 1 1
Rash 1 1
Skin Erosion 1 1
Injury 1 1
Pressure Sore/Ulcer 1 1
Fluid Discharge 1 1
Muscle/Tendon Damage 1 1
Skin Tears 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 KOB GmbH II Mar-06-2026
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