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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
2016 14 14
2017 93 93
2018 19 19
2019 19 19
2020 11 11
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 79 79
Adverse Event Without Identified Device or Use Problem 39 39
Detachment Of Device Component 9 9
Insufficient Information 5 5
Patient Device Interaction Problem 5 5
Device Subassembly 4 4
Fungus in Device Environment 3 3
Device Packaging Compromised 3 3
Break 3 3
Mechanical Jam 2 2
Patient-Device Incompatibility 2 2
Device Operates Differently Than Expected 2 2
No Apparent Adverse Event 1 1
Crack 1 1
Gel Leak 1 1
Device Emits Odor 1 1
Off-Label Use 1 1
Device Slipped 1 1
Component Missing 1 1
Cord 1 1
Loss of or Failure to Bond 1 1
Device Markings/Labelling Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Mechanics Altered 1 1
Peeled/Delaminated 1 1
Inadequacy of Device Shape and/or Size 1 1
Improper or Incorrect Procedure or Method 1 1
Sharp Edges 1 1
Device Fell 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 59 59
No Consequences Or Impact To Patient 28 28
Itching Sensation 16 16
Skin Irritation 14 14
Rash 10 10
Erythema 9 9
Swelling 8 8
Pain 6 6
No Patient Involvement 5 5
Fall 5 5
Injury 4 4
Bone Fracture(s) 4 4
Cellulitis 3 3
Numbness 3 3
Hypersensitivity/Allergic reaction 2 2
Rupture 2 2
Unspecified Infection 2 2
Damage to Ligament(s) 2 2
Burning Sensation 2 2
Patient Problem/Medical Problem 2 2
No Information 2 2
Reaction 2 2
Suture Abrasion 1 1
Bacterial Infection 1 1
No Code Available 1 1
Skin Inflammation/ Irritation 1 1
Discomfort 1 1
Arthralgia 1 1
Joint Disorder 1 1
Necrosis 1 1
Local Reaction 1 1
Tissue Damage 1 1
Purulent Discharge 1 1
Pressure Sores 1 1
Deformity/ Disfigurement 1 1
Spinal Column Injury 1 1
Inflammation 1 1
Irritation 1 1
Abrasion 1 1
Arthritis 1 1
Burn(s) 1 1
Cyst(s) 1 1
Fungal Infection 1 1
Skin Tears 1 1
Ambulation Difficulties 1 1
Caustic/Chemical Burns 1 1
Fluid Discharge 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Mar-09-2018
2 DeRoyal Industries Inc II Dec-06-2016
3 Ossur H / F II Mar-31-2016
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