TPLC - Total Product Life Cycle

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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)
2021	2022	2023	2024	2025	2026
3	6	4	3	6	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	3133	3134
Mechanical Problem	2360	2360
Fluid/Blood Leak	2077	2078
Material Puncture/Hole	1162	1162
Insufficient Information	802	802
Inadequacy of Device Shape and/or Size	800	800
Migration	327	327
Defective Device	319	319
Malposition of Device	218	218
Inflation Problem	157	157
Decrease in Pressure	107	107
Air/Gas in Device	60	60
Difficult or Delayed Activation	50	50
Disconnection	44	44
Deflation Problem	37	37
Use of Device Problem	35	36
Device Contamination with Chemical or Other Material	20	20
Improper or Incorrect Procedure or Method	13	14
Nonstandard Device	12	12
Material Deformation	12	12
Device Remains Activated	9	9
Detachment of Device or Device Component	9	9
Migration or Expulsion of Device	8	8
Increase in Pressure	6	6
Patient Device Interaction Problem	6	6
Material Discolored	6	6
Unintended Movement	5	5
Human-Device Interface Problem	4	4
Therapeutic or Diagnostic Output Failure	4	4
Positioning Problem	4	4
Break	3	3
Contamination	3	3
Difficult to Open or Close	3	3
Material Split, Cut or Torn	2	2
Difficult or Delayed Positioning	2	2
Device Contaminated During Manufacture or Shipping	2	2
Collapse	2	2
Device Appears to Trigger Rejection	2	2
Connection Problem	2	2
Unsealed Device Packaging	2	2
Self-Activation or Keying	2	2
Material Erosion	2	2
Shipping Damage or Problem	1	1
Microbial Contamination of Device	1	1
Device Markings/Labelling Problem	1	1
Component Missing	1	1
Pressure Problem	1	1
Device Damaged by Another Device	1	1
Infusion or Flow Problem	1	1
Lack of Effect	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Urinary Incontinence	5343	5344
No Clinical Signs, Symptoms or Conditions	1860	1860
Unspecified Tissue Injury	1406	1406
Erosion	1071	1071
Unspecified Infection	321	321
Urinary Retention	222	222
Pain	195	195
Incontinence	192	192
Insufficient Information	154	154
Discomfort	99	99
Perforation	87	88
Swelling/ Edema	80	80
Hematuria	48	48
Dysuria	45	45
Inflammation	43	43
Urethral Stenosis/Stricture	37	37
Internal Organ Perforation	35	36
Scar Tissue	34	34
Hematoma	28	28
Urinary Tract Infection	24	24
Hemorrhage/Bleeding	22	22
Fever	19	19
Abscess	18	18
No Known Impact Or Consequence To Patient	17	17
Tissue Damage	15	15
Wound Dehiscence	14	14
Hernia	14	14
Adhesion(s)	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	13	13
Purulent Discharge	13	13
Implant Pain	12	12
Fistula	11	11
Fluid Discharge	11	11
Fibrosis	10	10
Capsular Contracture	9	9
Erythema	9	9
No Consequences Or Impact To Patient	9	9
Burning Sensation	8	8
Necrosis	7	7
Hypersensitivity/Allergic reaction	7	7
Post Operative Wound Infection	6	6
Anxiety	6	6
Failure of Implant	6	6
Micturition Urgency	6	6
Abdominal Pain	6	6
Obstruction/Occlusion	5	5
Bacterial Infection	5	5
Skin Inflammation/ Irritation	4	4
Calcium Deposits/Calcification	4	4
Foreign Body In Patient	4	4

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