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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device orthosis, limb brace
Regulation Description Limb orthosis.
Product CodeIQI
Regulation Number 890.3475
Device Class 1

MDR Year MDR Reports MDR Events
2021 9 9
2022 11 14
2023 3 3
2024 2 2
2025 8 8
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 14 15
Patient Device Interaction Problem 4 4
Unintended Movement 2 2
Inadequacy of Device Shape and/or Size 2 2
Fitting Problem 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Device Markings/Labelling Problem 1 2
Human-Device Interface Problem 1 1
Fracture 1 1
Mechanical Problem 1 1
Product Quality Problem 1 2
Device Appears to Trigger Rejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Inflammation/ Irritation 8 8
Itching Sensation 6 6
Rash 5 5
Erythema 5 5
Abrasion 4 4
Pain 4 4
No Clinical Signs, Symptoms or Conditions 3 4
Blister 3 3
Unspecified Infection 2 2
Hypersensitivity/Allergic reaction 2 2
Nerve Damage 2 2
Fall 2 2
Malunion of Bone 2 2
Bruise/Contusion 2 2
Skin Infection 1 1
Hip Fracture 1 1
Fungal Infection 1 2
Bone Fracture(s) 1 1
Hematoma 1 1
Inflammation 1 1
Muscle Weakness 1 2
Local Reaction 1 1
Localized Skin Lesion 1 2
Burn(s) 1 1
Numbness 1 1
Insufficient Information 1 1
Laceration(s) 1 1
Limb Fracture 1 1
Muscle/Tendon Damage 1 2
Contact Dermatitis 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Bacterial Infection 1 2
Hemorrhage/Bleeding 1 1
Skin Burning Sensation 1 1
External Prosthetic Device Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Townsend Design II Jan-05-2024
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