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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device agent, bulking, injectable for gastro-urology use
Product CodeLNM
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
Break 9 9
Patient-Device Incompatibility 9 9
Material Erosion 8 8
Device Operates Differently Than Expected 7 7
Unexpected Therapeutic Results 6 6
No Apparent Adverse Event 4 4
Improper or Incorrect Procedure or Method 4 4
Malposition of Device 3 3
Difficult to Remove 3 3
Calcified 3 3
Patient Device Interaction Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Off-Label Use 1 1
Device Operational Issue 1 1
Entrapment of Device 1 1
Burst Container or Vessel 1 1
Contamination /Decontamination Problem 1 1
Bent 1 1
Obstruction of Flow 1 1
Use of Device Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Migration 1 1
Difficult to Advance 1 1
Positioning Problem 1 1
Defective Device 1 1
Shelf Life Exceeded 1 1
No Flow 1 1
Detachment Of Device Component 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
Internal Organ Perforation 12 12
No Code Available 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
Constipation 8 8
Hemorrhage/Bleeding 8 8
Scar Tissue 8 8
Discomfort 8 8
Abdominal Distention 8 8
Abdominal Pain 8 8
Hematoma 7 7
Fever 7 7
Sepsis 6 6
Insufficient Information 6 6
Foreign Body In Patient 6 6
Stenosis 5 5
Abnormal Vaginal Discharge 5 5
Swelling 5 5
Chills 5 5
Renal Failure 4 4
Nausea 4 4
Urinary Incontinence 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Failure of Implant 4 4
No Information 4 4
Muscle Spasm(s) 4 4
Complaint, Ill-Defined 4 4
Granuloma 4 4
Adhesion(s) 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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