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TPLC
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Device
implant, dermal, for aesthetic use
Product Code
LMH
Device Class
3
Premarket Approvals (PMA)
2019
2020
2021
2022
2023
2024
68
61
51
40
81
18
MDR Year
MDR Reports
MDR Events
2019
1272
1272
2020
1155
1155
2021
1422
1422
2022
1358
1358
2023
1478
1478
2024
249
249
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
5444
5444
Improper or Incorrect Procedure or Method
798
798
Off-Label Use
257
257
Patient-Device Incompatibility
124
124
Use of Device Problem
75
75
Detachment of Device or Device Component
57
57
Insufficient Information
57
57
Gel Leak
53
53
Migration
35
35
Device Appears to Trigger Rejection
28
28
Break
23
23
Migration or Expulsion of Device
20
20
No Apparent Adverse Event
19
19
Crack
17
17
Output Problem
14
14
Patient Device Interaction Problem
13
13
Product Quality Problem
11
11
Difficult or Delayed Activation
11
11
Unintended Ejection
7
7
Appropriate Term/Code Not Available
7
7
Burst Container or Vessel
6
6
Delivered as Unsterile Product
4
4
Malposition of Device
4
4
Contamination of Device Ingredient or Reagent
3
3
Contamination
3
3
Positioning Problem
3
3
Human-Device Interface Problem
3
3
Expulsion
2
2
Device Contamination with Chemical or Other Material
2
2
Therapeutic or Diagnostic Output Failure
2
2
Device Handling Problem
2
2
Missing Information
2
2
Use of Incorrect Control/Treatment Settings
2
2
Defective Device
2
2
Dull, Blunt
1
1
Obstruction of Flow
1
1
Biofilm coating in Device
1
1
Contamination /Decontamination Problem
1
1
Device Ingredient or Reagent Problem
1
1
Device Markings/Labelling Problem
1
1
Device Dislodged or Dislocated
1
1
Coagulation in Device or Device Ingredient
1
1
Fluid/Blood Leak
1
1
Material Fragmentation
1
1
Particulates
1
1
Excess Flow or Over-Infusion
1
1
Loose or Intermittent Connection
1
1
Retraction Problem
1
1
Material Too Rigid or Stiff
1
1
Material Rupture
1
1
Device Slipped
1
1
Unexpected Therapeutic Results
1
1
Air/Gas in Device
1
1
Ejection Problem
1
1
Misassembly by Users
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Inflammation
936
936
Obstruction/Occlusion
799
799
Nodule
790
790
Unspecified Infection
784
784
Skin Irritation
718
718
Abscess
517
517
Subcutaneous Nodule
408
408
Edema
373
373
Swelling/ Edema
359
359
Pain
333
333
Granuloma
302
302
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
300
300
Hypersensitivity/Allergic reaction
295
295
Vascular System (Circulation), Impaired
284
284
Necrosis
269
269
Erythema
229
229
No Code Available
228
228
Viral Infection
169
169
Foreign Body Embolism
165
165
Swelling
152
152
Skin Discoloration
147
147
Bacterial Infection
115
115
Cellulitis
112
112
Bruise/Contusion
99
99
Skin Inflammation/ Irritation
99
99
No Consequences Or Impact To Patient
97
97
Ischemia
88
88
Foreign Body Reaction
86
86
Respiratory Tract Infection
83
83
Skin Infection
83
83
Urinary Tract Infection
73
73
Purulent Discharge
70
70
Swollen Lymph Nodes/Glands
69
69
Deformity/ Disfigurement
64
64
Loss of Vision
61
61
Pallor
56
56
Implant Pain
56
56
Injection Site Reaction
55
55
Occlusion
49
49
Blurred Vision
43
43
Angioedema
42
42
Embolism/Embolus
42
42
Autoimmune Disorder
42
42
Fluid Discharge
41
41
Headache
40
40
No Clinical Signs, Symptoms or Conditions
39
39
Anaphylactic Shock
38
38
Discomfort
38
38
Visual Impairment
35
35
Hematoma
34
34
Scarring
33
33
Rash
32
32
Unspecified Vascular Problem
32
32
Numbness
31
31
Itching Sensation
31
31
Scar Tissue
30
30
Patient Problem/Medical Problem
30
30
Skin Inflammation
29
29
Cytomegalovirus (CMV) Infection
28
28
Skin Erosion
28
28
Fever
27
27
Dyspnea
26
26
Stroke/CVA
26
26
Nausea
24
24
Visual Disturbances
22
22
Anxiety
21
21
Ecchymosis
21
21
Urticaria
20
20
Reaction
20
20
Cyst(s)
18
18
Ptosis
16
16
Fibrosis
16
16
Easy Bruising
15
15
Hemorrhage/Bleeding
15
15
Paralysis
15
15
Local Reaction
15
15
Sepsis
14
14
Deposits
14
14
Depression
14
14
Blister
13
13
Cancer
13
13
Dysphagia/ Odynophagia
13
13
Pneumonia
13
13
Nerve Damage
13
13
Irritation
12
12
Swollen Lymph Nodes
12
12
Dizziness
12
12
Ulcer
12
12
Vomiting
12
12
Tachycardia
11
11
Breast Cancer
11
11
Insufficient Information
11
11
Hair Loss
10
10
Facial Nerve Paralysis
10
10
Fatigue
10
10
Burning Sensation
10
10
Malaise
10
10
No Known Impact Or Consequence To Patient
10
10
Unspecified Eye / Vision Problem
10
10
Eye Pain
9
9
Recalls
Manufacturer
Recall Class
Date Posted
1
Prollenium Medical Technologies Inc.
II
Feb-11-2020
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