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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)
2019 2020 2021 2022 2023 2024
10 23 5 13 14 3

MDR Year MDR Reports MDR Events
2019 8 8
2020 7 7
2021 11 11
2022 18 18
2023 16 16
2024 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 36 36
Insufficient Information 7 7
Unexpected Therapeutic Results 6 6
Patient-Device Incompatibility 4 4
Material Erosion 3 3
Migration or Expulsion of Device 2 2
Malposition of Device 2 2
Patient Device Interaction Problem 1 1
Contamination /Decontamination Problem 1 1
Device Contamination with Chemical or Other Material 1 1
No Apparent Adverse Event 1 1
Off-Label Use 1 1
Break 1 1
Calcified 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Obstruction of Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Urinary Tract Infection 13 13
Urinary Retention 10 10
Calcium Deposits/Calcification 9 9
Hypersensitivity/Allergic reaction 8 8
Itching Sensation 8 8
Rash 8 8
Pain 6 6
Obstruction/Occlusion 5 5
Incontinence 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Urinary Incontinence 4 4
Hematoma 4 4
Injury 4 4
Hematuria 4 4
Insufficient Information 3 3
No Clinical Signs, Symptoms or Conditions 3 3
No Code Available 3 3
Renal Impairment 2 2
Unspecified Kidney or Urinary Problem 2 2
Genital Bleeding 2 2
Dysuria 2 2
Sepsis 2 2
Myalgia 2 2
Urinary Frequency 2 2
Abdominal Pain 2 2
Abscess 2 2
Cyst(s) 2 2
Failure of Implant 2 2
Unspecified Infection 1 1
Muscle Spasm(s) 1 1
Nausea 1 1
Necrosis 1 1
Fever 1 1
Foreign Body Reaction 1 1
Granuloma 1 1
Headache 1 1
Erosion 1 1
Hemorrhage/Bleeding 1 1
Discomfort 1 1
Test Result 1 1
Abdominal Distention 1 1
Numbness 1 1
Prolapse 1 1
Subcutaneous Nodule 1 1
Urethral Stenosis/Stricture 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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