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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)
2021 2022 2023 2024 2025 2026
5 13 14 8 7 2

MDR Year MDR Reports MDR Events
2021 11 11
2022 18 18
2023 16 16
2024 65 65
2025 61 61
2026 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Break 81 81
Adverse Event Without Identified Device or Use Problem 64 64
Insufficient Information 7 7
Unexpected Therapeutic Results 6 6
Malposition of Device 3 3
Appropriate Term/Code Not Available 3 3
Material Erosion 2 2
Defective Device 2 2
Patient Device Interaction Problem 2 2
Patient-Device Incompatibility 1 1
Contamination /Decontamination Problem 1 1
Use of Device Problem 1 1
Obstruction of Flow 1 1
Lack of Effect 1 1
Device Sensing Problem 1 1
Device Contamination with Chemical or Other Material 1 1
No Apparent Adverse Event 1 1
Migration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 55 55
Urinary Retention 23 23
Insufficient Information 19 19
Incontinence 18 18
Laceration(s) 17 17
Urinary Tract Infection 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Rash 9 9
Hypersensitivity/Allergic reaction 8 8
Calcium Deposits/Calcification 8 8
Itching Sensation 8 8
Obstruction/Occlusion 8 8
Dysuria 7 7
Pain 7 7
Abscess 6 6
Hematoma 6 6
Urinary Incontinence 5 5
Constipation 4 4
Urinary Frequency 4 4
Hematuria 4 4
Inflammation 3 3
Fever 3 3
Cyst(s) 3 3
Renal Impairment 3 3
Myalgia 2 2
Foreign Body Reaction 2 2
Discomfort 2 2
Unspecified Kidney or Urinary Problem 2 2
Genital Bleeding 2 2
Failure of Implant 2 2
Abdominal Pain 2 2
Urethral Stenosis/Stricture 1 1
Implant Pain 1 1
Abrasion 1 1
Abdominal Distention 1 1
Burning Sensation 1 1
Fecal Incontinence 1 1
Micturition Urgency 1 1
Nausea 1 1
Renal Failure 1 1
Swelling/ Edema 1 1
Hemorrhage/Bleeding 1 1
Sepsis 1 1
Subcutaneous Nodule 1 1
Unspecified Infection 1 1
Fibrosis 1 1
Fistula 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Axonics Modulation Technologies, Inc. II Jul-15-2021
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