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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 714 714

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 3665 3665
Fluid/Blood Leak 2190 2190
Adverse Event Without Identified Device or Use Problem 2108 2108
Mechanical Problem 2094 2094
Material Puncture/Hole 1118 1118
Inadequacy of Device Shape and/or Size 831 831
Defective Device 347 347
Migration 331 331
Malposition of Device 205 205
Inflation Problem 151 151
Decrease in Pressure 102 102
Failure to Cycle 79 79
Difficult or Delayed Activation 42 42
Use of Device Problem 37 37
Deflation Problem 31 31
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 15 15
Device Remains Activated 11 11
Improper or Incorrect Procedure or Method 11 11
Migration or Expulsion of Device 9 9
Material Erosion 8 8
Device Operates Differently Than Expected 7 7
Contamination 6 6
Material Discolored 6 6
Unstable 5 5
Gas/Air Leak 5 5
Self-Activation or Keying 5 5
Increase in Pressure 5 5
Detachment of Device or Device Component 5 5
Break 5 5
Expulsion 5 5
Patient Device Interaction Problem 4 4
Leak/Splash 4 4
Device Contaminated During Manufacture or Shipping 4 4
Connection Problem 4 4
Positioning Problem 3 3
Device Markings/Labelling Problem 3 3
Loose or Intermittent Connection 3 3
Material Rupture 2 2
Unintended Movement 2 2
Material Protrusion/Extrusion 2 2
Shipping Damage or Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Material Integrity Problem 2 2
Product Quality Problem 1 1
Corroded 1 1
Human-Device Interface Problem 1 1
Fracture 1 1
Activation Problem 1 1
Device Dislodged or Dislocated 1 1
Activation, Positioning or Separation Problem 1 1
Material Split, Cut or Torn 1 1
Component Missing 1 1
Lack of Effect 1 1
Premature Discharge of Battery 1 1
Delivered as Unsterile Product 1 1
Extrusion 1 1
Device Damaged by Another Device 1 1
Device-Device Incompatibility 1 1
Wrong Label 1 1
Free or Unrestricted Flow 1 1
Crack 1 1
Collapse 1 1
Material Perforation 1 1
Stretched 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Urinary Incontinence 3112 3112
Incontinence 2272 2272
No Known Impact Or Consequence To Patient 2110 2110
Erosion 1262 1262
No Clinical Signs, Symptoms or Conditions 1232 1232
Unspecified Tissue Injury 905 905
Tissue Damage 621 621
Unspecified Infection 444 444
No Consequences Or Impact To Patient 297 297
Urinary Retention 236 236
Pain 192 192
Insufficient Information 139 139
Perforation 116 116
Discomfort 87 87
Dysuria 55 55
Swelling/ Edema 49 49
Inflammation 39 39
Hematuria 37 37
Hematoma 32 32
Urinary Tract Infection 29 29
Scar Tissue 29 29
Complaint, Ill-Defined 28 28
Internal Organ Perforation 26 26
Swelling 21 21
Urethral Stenosis/Stricture 21 21
Fistula 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
Purulent Discharge 11 11
Obstruction/Occlusion 11 11
No Code Available 10 10
Capsular Contracture 10 10
Failure of Implant 9 9
Fibrosis 9 9
Implant Pain 9 9
Burning Sensation 8 8
Hernia 8 8
Stenosis 8 8
Bacterial Infection 8 8
Hypersensitivity/Allergic reaction 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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