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TPLC
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show TPLC since
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2024
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Device
elastomer, silicone block
Product Code
MIB
Regulation Number
874.3620
Device Class
2
Premarket Reviews
Manufacturer
Decision
AUGMENTA LLC
SUBSTANTIALLY EQUIVALENT
1
INTERNATIONAL MEDICAL DEVICES, INC.
SUBSTANTIALLY EQUIVALENT
3
KEOSAN TRADING CO.
SUBSTANTIALLY EQUIVALENT
1
METALWARE TECHNOLOGY CORP.
SUBSTANTIALLY EQUIVALENT
1
SHINEO TECHNOLOGY CO., LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
3
3
2020
1
1
2021
5
5
2022
19
19
2023
74
74
2024
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
30
30
Insufficient Information
20
20
Use of Device Problem
14
14
Migration or Expulsion of Device
11
11
Patient Device Interaction Problem
9
9
Product Quality Problem
6
6
Malposition of Device
4
4
Inadequacy of Device Shape and/or Size
4
4
Device Appears to Trigger Rejection
4
4
Patient-Device Incompatibility
3
3
Break
3
3
Material Protrusion/Extrusion
3
3
No Apparent Adverse Event
3
3
Improper or Incorrect Procedure or Method
2
2
Material Fragmentation
2
2
Use of Incorrect Control/Treatment Settings
2
2
Microbial Contamination of Device
1
1
Fracture
1
1
Positioning Problem
1
1
Material Integrity Problem
1
1
Difficult to Insert
1
1
Migration
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
29
29
Deformity/ Disfigurement
25
25
Swelling/ Edema
25
25
Failure of Implant
20
20
Seroma
18
18
Decreased Sensitivity
17
17
Erosion
16
16
Scar Tissue
15
15
Implant Pain
10
10
Sexual Dysfunction
8
8
Inflammation
8
8
Depression
8
8
Post Operative Wound Infection
8
8
Unspecified Infection
6
6
Numbness
6
6
Nerve Damage
6
6
Erectile Dysfunction
6
6
Insufficient Information
5
5
Emotional Changes
4
4
Bacterial Infection
4
4
Wound Dehiscence
3
3
Wrinkling
3
3
Fluid Discharge
3
3
Skin Erosion
3
3
Unspecified Tissue Injury
2
2
Capsular Contracture
2
2
Hematoma
2
2
Perforation
2
2
Skin Inflammation/ Irritation
2
2
Dysuria
2
2
Drug Resistant Bacterial Infection
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Foreign Body Reaction
1
1
Cellulitis
1
1
Blister
1
1
Anaphylactoid
1
1
Discomfort
1
1
Edema
1
1
Asthma
1
1
Adhesion(s)
1
1
Tachycardia
1
1
Fungal Infection
1
1
Tissue Damage
1
1
Immunodeficiency
1
1
Sepsis
1
1
Unspecified Vascular Problem
1
1
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