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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)
2017 2018 2019 2020 2021 2022 2023 2024
12 12 10 10 3 6 4 0

MDR Year MDR Reports MDR Events
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 3642 3642
Fluid/Blood Leak 2135 2135
Adverse Event Without Identified Device or Use Problem 2047 2047
Mechanical Problem 2046 2046
Material Puncture/Hole 1096 1096
Inadequacy of Device Shape and/or Size 813 813
Defective Device 341 341
Migration 326 326
Malposition of Device 200 200
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 29 29
Material Deformation 26 26
Air/Gas in Device 26 26
Appropriate Term/Code Not Available 20 20
Device Contamination with Chemical or Other Material 14 14
Improper or Incorrect Procedure or Method 11 11
Device Remains Activated 11 11
Migration or Expulsion of Device 9 9
Material Erosion 8 8
Device Operates Differently Than Expected 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
Leak/Splash 4 4
Loose or Intermittent Connection 3 3
Positioning Problem 3 3
Device Markings/Labelling Problem 3 3
Therapeutic or Diagnostic Output Failure 2 2
Material Integrity Problem 2 2
Material Protrusion/Extrusion 2 2
Shipping Damage or Problem 2 2
Material Rupture 2 2
Product Quality Problem 1 1
Premature Discharge of Battery 1 1
Stretched 1 1
Material Perforation 1 1
Component Missing 1 1
Fracture 1 1
Delivered as Unsterile Product 1 1
No Device Output 1 1
Collapse 1 1
Corroded 1 1
Crack 1 1
Unintended Movement 1 1
Material Split, Cut or Torn 1 1
Activation Problem 1 1
Lack of Effect 1 1
Wrong Label 1 1
Extrusion 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Urinary Incontinence 2973 2973
Incontinence 2271 2271
No Known Impact Or Consequence To Patient 2110 2110
Erosion 1243 1243
No Clinical Signs, Symptoms or Conditions 1202 1202
Unspecified Tissue Injury 880 880
Tissue Damage 621 621
Unspecified Infection 434 434
No Consequences Or Impact To Patient 297 297
Urinary Retention 231 231
Pain 188 188
Insufficient Information 136 136
Perforation 114 114
Discomfort 86 86
Dysuria 55 55
Swelling/ Edema 47 47
Inflammation 37 37
Hematuria 36 36
Hematoma 31 31
Complaint, Ill-Defined 28 28
Urinary Tract Infection 28 28
Scar Tissue 28 28
Internal Organ Perforation 26 26
Swelling 21 21
Fistula 20 20
Urethral Stenosis/Stricture 20 20
Hemorrhage/Bleeding 19 19
Wound Dehiscence 18 18
Adhesion(s) 18 18
Abscess 17 17
Injury 17 17
Fluid Discharge 16 16
Scarring 14 14
Fever 14 14
Capsular Contracture 10 10
Purulent Discharge 10 10
Obstruction/Occlusion 10 10
No Code Available 10 10
Implant Pain 9 9
Failure of Implant 9 9
Burning Sensation 8 8
Hernia 8 8
Stenosis 8 8
Bacterial Infection 8 8
Hypersensitivity/Allergic reaction 8 8
Fibrosis 8 8
Abdominal Pain 7 7
Cellulitis 6 6
Micturition Urgency 6 6
Necrosis 6 6
Anxiety 6 6
Sepsis 6 6
No Patient Involvement 5 5
Post Operative Wound Infection 5 5
Foreign Body In Patient 4 4
No Information 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Muscle Weakness 4 4
Irritation 4 4
Calcium Deposits/Calcification 4 4
Itching Sensation 3 3
Edema 3 3
Thrombosis 3 3
Urinary Frequency 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
Perforation of Vessels 2 2
Staphylococcus Aureus 2 2
Pneumonia 2 2
Pocket Erosion 2 2
Rash 2 2
Bruise/Contusion 2 2
Air Embolism 1 1
Aneurysm 1 1
Erythema 1 1
Extravasation 1 1
Fatigue 1 1
Death 1 1
Dehydration 1 1
Cardiac Arrest 1 1
Laceration(s) 1 1
Muscle Spasm(s) 1 1
Myocardial Infarction 1 1
Nerve Damage 1 1
Neuropathy 1 1
Foreign Body Reaction 1 1
Headache 1 1
Renal Failure 1 1
Seroma 1 1
Ulceration 1 1
Therapeutic Effects, Unexpected 1 1
Rupture 1 1
Therapeutic Response, Decreased 1 1
Ulcer 1 1
Pressure Sores 1 1
Ambulation Difficulties 1 1
Blood Loss 1 1
Constipation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Aug-30-2019
2 Uromedica Inc. II Jan-05-2022
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