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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
2017 93 93
2018 19 19
2019 19 19
2020 11 11
2021 9 9
2022 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 78 78
Adverse Event Without Identified Device or Use Problem 44 44
Detachment Of Device Component 9 9
Patient Device Interaction Problem 8 8
Insufficient Information 4 4
Inadequacy of Device Shape and/or Size 2 2
Break 2 2
Patient-Device Incompatibility 2 2
Device Markings/Labelling Problem 2 2
Device Operates Differently Than Expected 1 1
Human-Device Interface Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Mechanical Jam 1 1
Loss of or Failure to Bond 1 1
Positioning Problem 1 1
No Apparent Adverse Event 1 1
Device Slipped 1 1
Improper or Incorrect Procedure or Method 1 1
Component Missing 1 1
Crack 1 1
Device Emits Odor 1 1
Peeled/Delaminated 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Sharp Edges 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 55 55
No Consequences Or Impact To Patient 27 27
Itching Sensation 22 22
Erythema 14 14
Rash 13 13
Skin Irritation 13 13
Swelling 8 8
Skin Inflammation/ Irritation 8 8
No Patient Involvement 5 5
Fall 5 5
Bone Fracture(s) 4 4
Pain 4 4
Injury 4 4
Blister 3 3
Numbness 3 3
Hypersensitivity/Allergic reaction 3 3
Unspecified Infection 3 3
Inflammation 2 2
Bacterial Infection 2 2
Bruise/Contusion 2 2
Fungal Infection 2 2
Nerve Damage 2 2
Burning Sensation 2 2
No Information 2 2
Reaction 2 2
Patient Problem/Medical Problem 2 2
Insufficient Information 2 2
No Clinical Signs, Symptoms or Conditions 1 1
No Code Available 1 1
Muscle/Tendon Damage 1 1
Deformity/ Disfigurement 1 1
Fluid Discharge 1 1
Skin Burning Sensation 1 1
Localized Skin Lesion 1 1
Skin Infection 1 1
Contact Dermatitis 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Spinal Column Injury 1 1
Local Reaction 1 1
Skin Tears 1 1
Caustic/Chemical Burns 1 1
Rupture 1 1
Pressure Sores 1 1
Discomfort 1 1
Burn(s) 1 1
Cellulitis 1 1
Cyst(s) 1 1
Purulent Discharge 1 1
Hemorrhage/Bleeding 1 1
Irritation 1 1
Damage to Ligament(s) 1 1
Muscle Weakness 1 1
Necrosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Mar-09-2018
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