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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
Product CodeIQI
Regulation Number 890.3475
Device Class 1

MDR Year MDR Reports MDR Events
2019 19 19
2020 11 11
2021 9 9
2022 11 11
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 29 29
Patient Device Interaction Problem 8 8
Inadequacy of Device Shape and/or Size 2 2
Break 2 2
Device Slipped 1 1
Crack 1 1
Positioning Problem 1 1
Sharp Edges 1 1
Device Markings/Labelling Problem 1 1
Device Emits Odor 1 1
Mechanical Jam 1 1
Material Separation 1 1
No Apparent Adverse Event 1 1
Product Quality Problem 1 1
Device Fell 1 1
Improper or Incorrect Procedure or Method 1 1
Human-Device Interface Problem 1 1
Fracture 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Itching Sensation 16 16
Erythema 11 11
Skin Irritation 11 11
Skin Inflammation/ Irritation 8 8
Rash 6 6
Swelling 5 5
Fall 4 4
Unspecified Infection 3 3
Blister 3 3
Patient Problem/Medical Problem 2 2
Injury 2 2
Inflammation 2 2
Nerve Damage 2 2
Pain 2 2
Abrasion 2 2
Bruise/Contusion 2 2
Hypersensitivity/Allergic reaction 2 2
Fungal Infection 2 2
Insufficient Information 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Skin Tears 1 1
No Patient Involvement 1 1
Contact Dermatitis 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Bacterial Infection 1 1
Bone Fracture(s) 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Irritation 1 1
Laceration(s) 1 1
Muscle Weakness 1 1
Necrosis 1 1
Deformity/ Disfigurement 1 1
Reaction 1 1
Numbness 1 1
Burning Sensation 1 1
Discomfort 1 1
Spinal Column Injury 1 1
No Code Available 1 1
Limb Fracture 1 1
Muscle/Tendon Damage 1 1
Skin Burning Sensation 1 1
Localized Skin Lesion 1 1
Skin Infection 1 1

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