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TPLC
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show TPLC since
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Device
components, exercise
Product Code
IOD
Regulation Number
890.5350
Device Class
1
MDR Year
MDR Reports
MDR Events
2016
2
2
2017
144
144
2018
15
15
2019
1
1
2023
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
55
55
Insufficient Information
37
37
Device Operates Differently Than Expected
30
30
Patient-Device Incompatibility
26
26
Appropriate Term/Code Not Available
4
4
Unexpected Therapeutic Results
3
3
Material Integrity Problem
3
3
Labelling, Instructions for Use or Training Problem
2
2
Product Quality Problem
1
1
Fracture
1
1
Improper or Incorrect Procedure or Method
1
1
Inadequate Instructions for Non-Healthcare Professional
1
1
Break
1
1
Patient Device Interaction Problem
1
1
Battery Problem
1
1
Use of Device Problem
1
1
Device Unsafe to Use in Environment
1
1
Defective Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Weight Changes
56
56
Pain
48
48
Bruise/Contusion
36
36
No Code Available
32
32
Fatigue
27
27
Depression
20
20
Inflammation
19
19
Headache
17
17
Menstrual Irregularities
16
16
Swelling
15
15
Anxiety
15
15
Nausea
14
14
Complaint, Ill-Defined
13
13
Cellulitis
12
12
Tissue Damage
9
9
Dizziness
8
8
Emotional Changes
8
8
Lethargy
7
7
Heavier Menses
6
6
Rash
6
6
Arthralgia
6
6
Inadequate Pain Relief
6
6
Diarrhea
6
6
Thyroid Problems
6
6
Sleep Dysfunction
5
5
Abdominal Distention
5
5
Tissue Breakdown
5
5
Ambulation Difficulties
5
5
Weakness
4
4
Injury
4
4
Vomiting
4
4
Vertigo
4
4
Therapeutic Response, Decreased
4
4
Irritability
4
4
Cyst(s)
4
4
Malaise
4
4
Palpitations
4
4
Reaction
4
4
Confusion/ Disorientation
3
3
Skin Discoloration
3
3
Skin Inflammation
3
3
Itching Sensation
3
3
Abdominal Cramps
3
3
Toxicity
3
3
Test Result
3
3
Memory Loss/Impairment
3
3
Hemorrhage/Bleeding
3
3
Skin Irritation
3
3
Sweating
3
3
Thrombus
3
3
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