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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
7
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
36
36
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
272
272
Insufficient Information
30
30
Appropriate Term/Code Not Available
14
14
Migration or Expulsion of Device
10
10
Patient-Device Incompatibility
9
9
Break
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
Difficult to Remove
3
3
Calcified
3
3
Malposition of Device
3
3
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Patient Device Interaction Problem
2
2
Contamination /Decontamination Problem
1
1
Obstruction of Flow
1
1
Use of Device Problem
1
1
No Flow
1
1
Difficult to Advance
1
1
Positioning Problem
1
1
Defective Device
1
1
Bent
1
1
Device Contamination with Chemical or Other Material
1
1
Migration
1
1
Detachment Of Device Component
1
1
Device Operational Issue
1
1
Burst Container or Vessel
1
1
Entrapment of Device
1
1
Off-Label Use
1
1
Shelf Life Exceeded
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Incontinence
120
120
Urinary Tract Infection
85
85
Pain
77
77
Unspecified Infection
58
58
Micturition Urgency
57
57
Injury
48
48
Erosion
39
39
Obstruction/Occlusion
36
36
Urinary Frequency
32
32
Urinary Retention
30
30
Dysuria
22
22
Inflammation
21
21
Prolapse
20
20
Hematuria
18
18
Blood Loss
17
17
Calcium Deposits/Calcification
14
14
Itching Sensation
13
13
No Code Available
12
12
Internal Organ Perforation
12
12
Abscess
10
10
Test Result
10
10
No Known Impact Or Consequence To Patient
10
10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
9
9
Hypersensitivity/Allergic reaction
9
9
Rash
9
9
Abdominal Pain
8
8
Scar Tissue
8
8
Discomfort
8
8
Hemorrhage/Bleeding
8
8
Abdominal Distention
8
8
Constipation
8
8
Fever
7
7
Hematoma
7
7
Insufficient Information
6
6
Sepsis
6
6
Foreign Body In Patient
6
6
Stenosis
5
5
Swelling
5
5
Chills
5
5
Abnormal Vaginal Discharge
5
5
Renal Failure
4
4
Complaint, Ill-Defined
4
4
Failure of Implant
4
4
Muscle Spasm(s)
4
4
Nausea
4
4
Urinary Incontinence
4
4
No Clinical Signs, Symptoms or Conditions
4
4
No Information
4
4
Cyst(s)
4
4
Granuloma
4
4
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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