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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
12 12 10 10 3 6

MDR Year MDR Reports MDR Events
2017 9 9
2018 873 873
2019 2753 2753
2020 1743 1743
2021 1697 1697
2022 1337 1337

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 3379 3379
Fluid/Blood Leak 1574 1574
Mechanical Problem 1399 1399
Adverse Event Without Identified Device or Use Problem 1329 1329
Material Puncture/Hole 774 774
Inadequacy of Device Shape and/or Size 565 565
Migration 244 244
Defective Device 232 232
Malposition of Device 138 138
Inflation Problem 83 83
Failure to Cycle 79 79
Decrease in Pressure 71 71
Difficult or Delayed Activation 27 27
Use of Device Problem 25 25
Material Deformation 22 22
Appropriate Term/Code Not Available 20 20
Deflation Problem 20 20
Disconnection 19 19
Device Remains Activated 10 10
Migration or Expulsion of Device 9 9
Material Erosion 7 7
Device Operates Differently Than Expected 7 7
Material Discolored 6 6
Contamination 6 6
Improper or Incorrect Procedure or Method 6 6
Unstable 5 5
Self-Activation or Keying 5 5
Expulsion 5 5
Gas/Air Leak 5 5
Connection Problem 4 4
Break 4 4
Leak/Splash 4 4
Loose or Intermittent Connection 3 3
Increase in Pressure 3 3
Device Markings/Labelling Problem 3 3
Device Contaminated During Manufacture or Shipping 3 3
Material Integrity Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Patient Device Interaction Problem 2 2
Shipping Damage or Problem 2 2
Material Rupture 2 2
Product Quality Problem 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
Premature Discharge of Battery 1 1
Corroded 1 1
Crack 1 1
Material Split, Cut or Torn 1 1
Activation Problem 1 1
Free or Unrestricted Flow 1 1
Human-Device Interface Problem 1 1
Material Protrusion/Extrusion 1 1
Activation, Positioning or Separation Problem 1 1
Detachment of Device or Device Component 1 1
Extrusion 1 1
Device Damaged by Another Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Incontinence 2257 2257
No Known Impact Or Consequence To Patient 2110 2110
Urinary Incontinence 1576 1576
Erosion 958 958
Tissue Damage 621 621
No Clinical Signs, Symptoms or Conditions 606 606
Unspecified Tissue Injury 534 534
Unspecified Infection 347 347
No Consequences Or Impact To Patient 297 297
Urinary Retention 161 161
Pain 144 144
Insufficient Information 114 114
Perforation 85 85
Discomfort 64 64
Dysuria 39 39
Complaint, Ill-Defined 28 28
Hematoma 27 27
Inflammation 26 26
Swelling/ Edema 25 25
Hematuria 24 24
Urinary Tract Infection 21 21
Swelling 21 21
Scar Tissue 21 21
Internal Organ Perforation 17 17
Injury 17 17
Fistula 15 15
Wound Dehiscence 14 14
Fever 14 14
Scarring 14 14
Adhesion(s) 13 13
Fluid Discharge 13 13
Abscess 11 11
Hemorrhage/Bleeding 10 10
No Code Available 10 10
Obstruction/Occlusion 9 9
Urethral Stenosis/Stricture 8 8
Stenosis 7 7
Burning Sensation 7 7
Hypersensitivity/Allergic reaction 7 7
Purulent Discharge 7 7
Bacterial Infection 6 6
Abdominal Pain 6 6
Failure of Implant 6 6
Sepsis 6 6
Anxiety 6 6
Hernia 5 5
Post Operative Wound Infection 5 5
Capsular Contracture 5 5
Cellulitis 5 5
No Patient Involvement 5 5
No Information 4 4
Irritation 4 4
Micturition Urgency 4 4
Muscle Weakness 4 4
Edema 3 3
Impaired Healing 3 3
Urinary Frequency 3 3
Thrombosis 3 3
Fibrosis 3 3
Foreign Body In Patient 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Cramp(s) /Muscle Spasm(s) 2 2
Patient Problem/Medical Problem 2 2
Implant Pain 2 2
Necrosis 2 2
Staphylococcus Aureus 2 2
Pneumonia 2 2
Itching Sensation 2 2
Laceration(s) 1 1
Muscle Spasm(s) 1 1
Rash 1 1
Renal Failure 1 1
Myocardial Infarction 1 1
Headache 1 1
Extravasation 1 1
Fatigue 1 1
Death 1 1
Dehydration 1 1
Cardiac Arrest 1 1
Air Embolism 1 1
Aneurysm 1 1
Calcium Deposits/Calcification 1 1
Seroma 1 1
Perforation of Vessels 1 1
Therapeutic Effects, Unexpected 1 1
Ulceration 1 1
Pressure Sores 1 1
Therapeutic Response, Decreased 1 1
Rupture 1 1
Ambulation Difficulties 1 1
Blood Loss 1 1
Decreased Appetite 1 1
Fecal Incontinence 1 1
Constipation 1 1
Bowel Perforation 1 1
Radiation Exposure, Unintended 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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