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

MDR Year MDR Reports MDR Events
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 3083 3083
Adverse Event Without Identified Device or Use Problem 2012 2012
Mechanical Problem 1999 1999
Fluid/Blood Leak 1981 1981
Material Puncture/Hole 1064 1064
Inadequacy of Device Shape and/or Size 767 767
Defective Device 330 330
Migration 308 308
Malposition of Device 189 189
Inflation Problem 148 148
Decrease in Pressure 91 91
Failure to Cycle 68 68
Difficult or Delayed Activation 41 41
Use of Device Problem 34 34
Deflation Problem 29 29
Disconnection 29 29
Air/Gas in Device 26 26
Material Deformation 25 25
Device Contamination with Chemical or Other Material 14 14
Device Remains Activated 11 11
Improper or Incorrect Procedure or Method 11 11
Migration or Expulsion of Device 8 8
Contamination 6 6
Break 5 5
Material Erosion 5 5
Material Discolored 5 5
Detachment of Device or Device Component 5 5
Expulsion 5 5
Device Contaminated During Manufacture or Shipping 4 4
Patient Device Interaction Problem 4 4
Increase in Pressure 4 4
Device Markings/Labelling Problem 3 3
Connection Problem 3 3
Loose or Intermittent Connection 3 3
Positioning Problem 3 3
Therapeutic or Diagnostic Output Failure 2 2
Material Integrity Problem 2 2
Material Protrusion/Extrusion 2 2
Gas/Air Leak 2 2
Unstable 2 2
Self-Activation or Keying 2 2
Shipping Damage or Problem 2 2
Stretched 1 1
Material Perforation 1 1
Component Missing 1 1
Device Damaged by Another Device 1 1
Device-Device Incompatibility 1 1
Device Dislodged or Dislocated 1 1
Material Rupture 1 1
Delivered as Unsterile Product 1 1
Leak/Splash 1 1
Collapse 1 1
Corroded 1 1
Crack 1 1
Human-Device Interface Problem 1 1
Free or Unrestricted Flow 1 1
Unintended Movement 1 1
Appropriate Term/Code Not Available 1 1
Lack of Effect 1 1
Wrong Label 1 1
Material Split, Cut or Torn 1 1
Activation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Urinary Incontinence 2973 2973
Incontinence 1927 1927
No Known Impact Or Consequence To Patient 1701 1701
No Clinical Signs, Symptoms or Conditions 1202 1202
Erosion 1153 1153
Unspecified Tissue Injury 880 880
Tissue Damage 537 537
Unspecified Infection 402 402
No Consequences Or Impact To Patient 278 278
Urinary Retention 214 214
Pain 177 177
Insufficient Information 136 136
Perforation 106 106
Discomfort 85 85
Dysuria 50 50
Swelling/ Edema 47 47
Hematuria 35 35
Inflammation 35 35
Hematoma 30 30
Complaint, Ill-Defined 27 27
Scar Tissue 26 26
Internal Organ Perforation 26 26
Urinary Tract Infection 25 25
Urethral Stenosis/Stricture 20 20
Hemorrhage/Bleeding 19 19
Fistula 19 19
Wound Dehiscence 18 18
Adhesion(s) 18 18
Swelling 17 17
Fluid Discharge 15 15
Scarring 14 14
Injury 14 14
Abscess 14 14
Fever 12 12
Obstruction/Occlusion 10 10
Capsular Contracture 9 9
Implant Pain 9 9
Fibrosis 8 8
Purulent Discharge 8 8
Bacterial Infection 8 8
Hypersensitivity/Allergic reaction 8 8
Burning Sensation 8 8
Hernia 8 8
Stenosis 6 6
Anxiety 6 6
Micturition Urgency 6 6
Abdominal Pain 6 6
Failure of Implant 5 5
Post Operative Wound Infection 5 5
Sepsis 5 5
Necrosis 5 5
No Patient Involvement 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Foreign Body In Patient 4 4
No Code Available 4 4
Calcium Deposits/Calcification 4 4
Muscle Weakness 4 4
Cellulitis 4 4
Irritation 3 3
Itching Sensation 3 3
Thrombosis 3 3
Impaired Healing 3 3
Urinary Frequency 3 3
Unspecified Kidney or Urinary Problem 3 3
Cramp(s) /Muscle Spasm(s) 3 3
Perforation of Vessels 2 2
Pneumonia 2 2
Pocket Erosion 2 2
Rash 2 2
Edema 2 2
Bruise/Contusion 2 2
Air Embolism 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
Headache 1 1
Foreign Body Reaction 1 1
Renal Failure 1 1
Staphylococcus Aureus 1 1
Seroma 1 1
Ulceration 1 1
Nerve Damage 1 1
Neuropathy 1 1
Therapeutic Effects, Unexpected 1 1
Pressure Sores 1 1
Therapeutic Response, Decreased 1 1
Ulcer 1 1
Ambulation Difficulties 1 1
Skin Inflammation/ Irritation 1 1
Constipation 1 1
Thrombosis/Thrombus 1 1
Decreased Appetite 1 1
Blood Loss 1 1
No Information 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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