TPLC - Total Product Life Cycle

show TPLC since

Device	device, incontinence, mechanical/hydraulic
Regulation Description	Implanted mechanical/hydraulic urinary continence device.
Definition	PMA to be filed by 12/26/00 (65 FR 57731 (9/26/00))
Product Code	EZY
Regulation Number	876.5280
Device Class	3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
10	3	6	4	3	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	2667	2667
Mechanical Problem	2168	2168
Fluid/Blood Leak	2000	2000
Insufficient Information	1485	1485
Material Puncture/Hole	1079	1079
Inadequacy of Device Shape and/or Size	771	771
Migration	316	316
Defective Device	308	308
Malposition of Device	210	210
Inflation Problem	147	147
Decrease in Pressure	94	94
Difficult or Delayed Activation	45	45
Air/Gas in Device	44	44
Disconnection	38	38
Deflation Problem	35	35
Use of Device Problem	34	34
Failure to Cycle	29	29
Material Deformation	20	20
Device Contamination with Chemical or Other Material	18	18
Improper or Incorrect Procedure or Method	14	14
Device Remains Activated	10	10
Migration or Expulsion of Device	10	10
Detachment of Device or Device Component	6	6
Contamination	6	6
Break	5	5
Patient Device Interaction Problem	5	5
Material Discolored	5	5
Device Contaminated During Manufacture or Shipping	4	4
Positioning Problem	4	4
Increase in Pressure	3	3
Material Erosion	3	3
Collapse	3	3
Device Markings/Labelling Problem	3	3
Shipping Damage or Problem	2	2
Component Missing	2	2
Therapeutic or Diagnostic Output Failure	2	2
Material Integrity Problem	2	2
Delivered as Unsterile Product	2	2
Unintended Movement	2	2
Material Protrusion/Extrusion	2	2
Human-Device Interface Problem	2	2
Self-Activation or Keying	2	2
Loose or Intermittent Connection	2	2
Expulsion	2	2
Stretched	1	1
Unsealed Device Packaging	1	1
Device Damaged by Another Device	1	1
Infusion or Flow Problem	1	1
Lack of Effect	1	1
Wrong Label	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Urinary Incontinence	4159	4159
No Clinical Signs, Symptoms or Conditions	1589	1589
Unspecified Tissue Injury	1134	1134
Erosion	1092	1092
Incontinence	920	920
No Known Impact Or Consequence To Patient	562	562
Unspecified Infection	357	357
Tissue Damage	245	245
Urinary Retention	220	220
Pain	189	189
Insufficient Information	149	149
No Consequences Or Impact To Patient	132	132
Perforation	95	95
Discomfort	91	91
Swelling/ Edema	65	65
Dysuria	50	50
Hematuria	41	41
Inflammation	39	39
Internal Organ Perforation	33	33
Scar Tissue	30	30
Hematoma	30	30
Urethral Stenosis/Stricture	26	26
Urinary Tract Infection	25	25
Hemorrhage/Bleeding	19	19
Fever	19	19
Fistula	16	16
Adhesion(s)	16	16
Wound Dehiscence	15	15
Abscess	15	15
Purulent Discharge	15	15
Fluid Discharge	13	13
Hernia	11	11
Implant Pain	10	10
Swelling	10	10
Fibrosis	9	9
Burning Sensation	9	9
Bacterial Infection	8	8
Capsular Contracture	8	8
Hypersensitivity/Allergic reaction	8	8
Obstruction/Occlusion	7	7
Post Operative Wound Infection	6	6
Scarring	6	6
Anxiety	6	6
Abdominal Pain	5	5
Erythema	5	5
Micturition Urgency	5	5
Complaint, Ill-Defined	5	5
Sepsis	5	5
Necrosis	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Nov-25-2024
2	Uromedica Inc.	II	Jan-05-2022