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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, incontinence, mechanical/hydraulic
Definition PMA to be filed by 12/26/00 (65 FR 57731 (9/26/00))
Product CodeEZY
Regulation Number 876.5280
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
7 6 4 8 2 4 9 14 12 12 10 10 3 6 4 0

MDR Year MDR Reports MDR Events
2014 9 9
2015 13 13
2016 6 6
2017 9 9
2018 873 873
2019 2753 2753
2020 1742 1742
2021 1697 1697
2022 1553 1553
2023 1778 1778
2024 521 521

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 3645 3645
Fluid/Blood Leak 2137 2137
Adverse Event Without Identified Device or Use Problem 2052 2052
Mechanical Problem 2048 2048
Material Puncture/Hole 1096 1096
Inadequacy of Device Shape and/or Size 813 813
Defective Device 341 341
Migration 326 326
Malposition of Device 202 202
Inflation Problem 149 149
Decrease in Pressure 98 98
Failure to Cycle 79 79
Difficult or Delayed Activation 42 42
Use of Device Problem 37 37
Deflation Problem 30 30
Disconnection 30 30
Material Deformation 26 26
Air/Gas in Device 26 26
Appropriate Term/Code Not Available 21 21
Device Contamination with Chemical or Other Material 14 14
Improper or Incorrect Procedure or Method 12 12
Device Remains Activated 11 11
Migration or Expulsion of Device 11 11
Device Operates Differently Than Expected 11 11
Material Erosion 10 10
Leak/Splash 7 7
Material Discolored 6 6
Contamination 6 6
Break 5 5
Self-Activation or Keying 5 5
Increase in Pressure 5 5
Unstable 5 5
Gas/Air Leak 5 5
Detachment of Device or Device Component 5 5
Expulsion 5 5
Connection Problem 4 4
Patient Device Interaction Problem 4 4
Device Contaminated During Manufacture or Shipping 4 4
Positioning Problem 3 3
Device Markings/Labelling Problem 3 3
Material Rupture 3 3
Loose or Intermittent Connection 3 3
Shipping Damage or Problem 2 2
Extrusion 2 2
Therapeutic or Diagnostic Output Failure 2 2
Material Integrity Problem 2 2
Material Protrusion/Extrusion 2 2
Unintended Movement 1 1
Pressure Problem 1 1
Material Split, Cut or Torn 1 1
Activation Problem 1 1
Lack of Effect 1 1
Wrong Label 1 1
Human-Device Interface Problem 1 1
Free or Unrestricted Flow 1 1
Activation, Positioning or Separation Problem 1 1
Device Damaged by Another Device 1 1
Device-Device Incompatibility 1 1
Device Dislodged or Dislocated 1 1
Product Quality Problem 1 1
Premature Discharge of Battery 1 1
Stretched 1 1
Device Inoperable 1 1
Material Perforation 1 1
Component Missing 1 1
Fracture 1 1
Hole In Material 1 1
Delivered as Unsterile Product 1 1
No Device Output 1 1
Collapse 1 1
Corroded 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Urinary Incontinence 2973 2973
Incontinence 2279 2279
No Known Impact Or Consequence To Patient 2111 2111
Erosion 1248 1248
No Clinical Signs, Symptoms or Conditions 1202 1202
Unspecified Tissue Injury 880 880
Tissue Damage 621 621
Unspecified Infection 437 437
No Consequences Or Impact To Patient 297 297
Urinary Retention 233 233
Pain 192 192
Insufficient Information 136 136
Perforation 114 114
Discomfort 86 86
Dysuria 55 55
Swelling/ Edema 47 47
Inflammation 38 38
Hematuria 37 37
Hematoma 33 33
Urinary Tract Infection 29 29
Complaint, Ill-Defined 29 29
Scar Tissue 28 28
Internal Organ Perforation 26 26
Swelling 24 24
Fistula 21 21
Urethral Stenosis/Stricture 20 20
Injury 19 19
Hemorrhage/Bleeding 19 19
Wound Dehiscence 18 18
Adhesion(s) 18 18
Abscess 17 17
Fluid Discharge 16 16
Scarring 15 15
Fever 14 14
Failure of Implant 12 12
No Code Available 12 12
Obstruction/Occlusion 11 11
Capsular Contracture 11 11
Purulent Discharge 10 10
Stenosis 9 9
Implant Pain 9 9
Fibrosis 8 8
Hernia 8 8
Burning Sensation 8 8
Hypersensitivity/Allergic reaction 8 8
Bacterial Infection 8 8
Abdominal Pain 7 7
Micturition Urgency 7 7
Thrombosis 7 7
Necrosis 6 6
Sepsis 6 6
Cellulitis 6 6
Anxiety 6 6
No Information 6 6
No Patient Involvement 5 5
Post Operative Wound Infection 5 5
Foreign Body In Patient 4 4
Urinary Frequency 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Calcium Deposits/Calcification 4 4
Edema 4 4
Irritation 4 4
Muscle Weakness 4 4
Renal Failure 3 3
Itching Sensation 3 3
Death 3 3
Pulmonary Embolism 3 3
Impaired Healing 3 3
Unspecified Kidney or Urinary Problem 3 3
Cramp(s) /Muscle Spasm(s) 3 3
Patient Problem/Medical Problem 2 2
Bruise/Contusion 2 2
Extravasation 2 2
Staphylococcus Aureus 2 2
Perforation of Vessels 2 2
Pneumonia 2 2
Pocket Erosion 2 2
Rash 2 2
Seroma 1 1
Myocardial Infarction 1 1
Nerve Damage 1 1
Neuropathy 1 1
Occlusion 1 1
Electrolyte Imbalance 1 1
Therapeutic Response, Decreased 1 1
Ulcer 1 1
Rupture 1 1
Tachycardia 1 1
Therapeutic Effects, Unexpected 1 1
Ulceration 1 1
Fatigue 1 1
Erythema 1 1
Headache 1 1
Foreign Body Reaction 1 1
Laceration(s) 1 1
Muscle Spasm(s) 1 1
Hypoxia 1 1
Dehydration 1 1
Cardiac Arrest 1 1
Air Embolism 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Medical Systems, Inc. II May-10-2013
2 American Medical Systems, Inc. II Jun-27-2011
3 Boston Scientific Corporation II Aug-30-2019
4 Uromedica Inc. II Jan-05-2022
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