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TPLC
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show TPLC since
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2024
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Device
orthosis, limb brace
Product Code
IQI
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
Break
2
2
Inadequacy of Device Shape and/or Size
2
2
Device Slipped
1
1
Improper or Incorrect Procedure or Method
1
1
Patient-Device Incompatibility
1
1
Device Markings/Labelling Problem
1
1
Human-Device Interface Problem
1
1
Mechanical Jam
1
1
Crack
1
1
Fracture
1
1
Device Emits Odor
1
1
Product Quality Problem
1
1
Material Separation
1
1
Sharp Edges
1
1
Device Fell
1
1
Positioning Problem
1
1
No Apparent Adverse Event
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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