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TPLC
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show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
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Device
agent, bulking, injectable for gastro-urology use
Product Code
LNM
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
18
9
10
12
12
16
7
3
7
7
10
23
5
13
14
2
MDR Year
MDR Reports
MDR Events
2014
52
52
2015
58
58
2016
71
71
2017
86
86
2018
36
36
2019
8
8
2020
7
7
2021
11
11
2022
18
18
2023
16
16
2024
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
256
256
Insufficient Information
30
30
Appropriate Term/Code Not Available
12
12
Migration or Expulsion of Device
10
10
Patient-Device Incompatibility
9
9
Material Erosion
8
8
Device Operates Differently Than Expected
7
7
Unexpected Therapeutic Results
6
6
Improper or Incorrect Procedure or Method
4
4
No Apparent Adverse Event
4
4
Break
4
4
Malposition of Device
3
3
Difficult to Remove
3
3
Calcified
3
3
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Defective Device
1
1
Shelf Life Exceeded
1
1
Entrapment of Device
1
1
Positioning Problem
1
1
Difficult to Advance
1
1
Device Contamination with Chemical or Other Material
1
1
Detachment Of Device Component
1
1
Patient Device Interaction Problem
1
1
Off-Label Use
1
1
Device Operational Issue
1
1
Burst Container or Vessel
1
1
Bent
1
1
Obstruction of Flow
1
1
Use of Device Problem
1
1
No Flow
1
1
Contamination /Decontamination Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Incontinence
117
117
Urinary Tract Infection
83
83
Pain
76
76
Unspecified Infection
58
58
Micturition Urgency
57
57
Injury
48
48
Erosion
39
39
Obstruction/Occlusion
33
33
Urinary Frequency
31
31
Urinary Retention
27
27
Prolapse
20
20
Dysuria
20
20
Inflammation
19
19
Hematuria
18
18
Blood Loss
17
17
Internal Organ Perforation
12
12
No Code Available
12
12
Calcium Deposits/Calcification
11
11
No Known Impact Or Consequence To Patient
10
10
Test Result
10
10
Abscess
9
9
Itching Sensation
9
9
Hemorrhage/Bleeding
8
8
Abdominal Pain
8
8
Abdominal Distention
8
8
Discomfort
8
8
Scar Tissue
8
8
Sepsis
6
6
Fever
6
6
Foreign Body In Patient
6
6
Constipation
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Hematoma
5
5
Hypersensitivity/Allergic reaction
5
5
Rash
5
5
Swelling
5
5
Abnormal Vaginal Discharge
5
5
Chills
5
5
Stenosis
5
5
Complaint, Ill-Defined
4
4
Renal Failure
4
4
Scarring
4
4
Muscle Spasm(s)
4
4
Failure of Implant
4
4
Granuloma
4
4
Adhesion(s)
4
4
Cyst(s)
4
4
No Information
4
4
No Clinical Signs, Symptoms or Conditions
3
3
Urinary Incontinence
3
3
Insufficient Information
3
3
Diarrhea
3
3
Nausea
3
3
Discharge
3
3
Vomiting
3
3
Therapeutic Response, Decreased
3
3
Depression
2
2
Reaction
2
2
Vaginal Mucosa Damage
2
2
Myalgia
2
2
Regurgitation
2
2
Septic Shock
2
2
Liver Damage/Dysfunction
2
2
Foreign Body Reaction
2
2
Erythema
2
2
Fibrosis
2
2
Unspecified Kidney or Urinary Problem
2
2
Genital Bleeding
2
2
Renal Impairment
2
2
Urethral Stenosis/Stricture
1
1
Patient Problem/Medical Problem
1
1
Fluid Discharge
1
1
Subcutaneous Nodule
1
1
Fistula
1
1
Headache
1
1
Dysphagia/ Odynophagia
1
1
Death
1
1
Deposits
1
1
Bacterial Infection
1
1
Cellulitis
1
1
Irritation
1
1
Necrosis
1
1
Muscular Rigidity
1
1
Raynauds Phenomenon
1
1
Overdose
1
1
Tissue Damage
1
1
Rupture
1
1
Weakness
1
1
Numbness
1
1
Reaction, Injection Site
1
1
Ambulation Difficulties
1
1
Disability
1
1
Malaise
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Axonics Modulation Technologies, Inc.
II
Jul-15-2021
2
Merz North America, Inc.
II
Nov-16-2020
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