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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 2

MDR Year MDR Reports MDR Events
2019 2753 2753
2020 1742 1742
2021 1697 1697
2022 1553 1553
2023 1778 1778
2024 1397 1397

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 3168 3168
Adverse Event Without Identified Device or Use Problem 2321 2321
Fluid/Blood Leak 2180 2180
Mechanical Problem 2173 2173
Material Puncture/Hole 1151 1151
Inadequacy of Device Shape and/or Size 839 839
Defective Device 364 364
Migration 340 340
Malposition of Device 213 213
Inflation Problem 152 152
Decrease in Pressure 105 105
Failure to Cycle 68 68
Difficult or Delayed Activation 46 46
Use of Device Problem 36 36
Disconnection 33 33
Air/Gas in Device 31 31
Deflation Problem 31 31
Material Deformation 26 26
Device Contamination with Chemical or Other Material 16 16
Improper or Incorrect Procedure or Method 14 14
Device Remains Activated 11 11
Migration or Expulsion of Device 10 10
Contamination 6 6
Break 5 5
Material Erosion 5 5
Detachment of Device or Device Component 5 5
Material Discolored 5 5
Expulsion 5 5
Patient Device Interaction Problem 5 5
Positioning Problem 4 4
Increase in Pressure 4 4
Device Contaminated During Manufacture or Shipping 4 4
Device Markings/Labelling Problem 3 3
Connection Problem 3 3
Loose or Intermittent Connection 3 3
Material Protrusion/Extrusion 2 2
Component Missing 2 2
Gas/Air Leak 2 2
Shipping Damage or Problem 2 2
Unstable 2 2
Self-Activation or Keying 2 2
Appropriate Term/Code Not Available 2 2
Therapeutic or Diagnostic Output Failure 2 2
Material Integrity Problem 2 2
Unintended Movement 2 2
Material Split, Cut or Torn 1 1
Stretched 1 1
Device-Device Incompatibility 1 1
Leak/Splash 1 1
Corroded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Urinary Incontinence 3499 3499
Incontinence 1968 1968
No Known Impact Or Consequence To Patient 1701 1701
No Clinical Signs, Symptoms or Conditions 1378 1378
Erosion 1253 1253
Unspecified Tissue Injury 992 992
Tissue Damage 537 537
Unspecified Infection 431 431
No Consequences Or Impact To Patient 278 278
Urinary Retention 240 240
Pain 191 191
Insufficient Information 148 148
Perforation 117 117
Discomfort 95 95
Swelling/ Edema 56 56
Dysuria 54 54
Hematuria 39 39
Inflammation 38 38
Hematoma 33 33
Internal Organ Perforation 31 31
Scar Tissue 28 28
Complaint, Ill-Defined 27 27
Urinary Tract Infection 27 27
Hemorrhage/Bleeding 22 22
Urethral Stenosis/Stricture 21 21
Fistula 20 20
Wound Dehiscence 19 19
Adhesion(s) 18 18
Fever 17 17
Swelling 17 17
Abscess 15 15
Fluid Discharge 15 15
Scarring 14 14
Injury 14 14
Obstruction/Occlusion 12 12
Implant Pain 10 10
Purulent Discharge 9 9
Bacterial Infection 9 9
Fibrosis 9 9
Capsular Contracture 9 9
Burning Sensation 9 9
Hypersensitivity/Allergic reaction 8 8
Hernia 8 8
Abdominal Pain 6 6
Stenosis 6 6
Micturition Urgency 6 6
Anxiety 6 6
Necrosis 5 5
Sepsis 5 5
Failure of Implant 5 5

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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