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)
2020	2021	2022	2023	2024	2025	2026
10	3	6	4	3	6	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	3539	3540
Mechanical Problem	2738	2738
Fluid/Blood Leak	2482	2483
Insufficient Information	1606	1606
Material Puncture/Hole	1348	1348
Inadequacy of Device Shape and/or Size	944	944
Migration	398	398
Defective Device	371	371
Malposition of Device	250	250
Inflation Problem	172	172
Decrease in Pressure	132	132
Air/Gas in Device	63	63
Difficult or Delayed Activation	53	53
Disconnection	49	49
Deflation Problem	40	40
Use of Device Problem	39	40
Nonstandard Device	37	37
Failure to Cycle	29	29
Material Deformation	23	23
Device Contamination with Chemical or Other Material	20	20
Improper or Incorrect Procedure or Method	15	16
Device Remains Activated	11	11
Human-Device Interface Problem	10	10
Migration or Expulsion of Device	10	10
Detachment of Device or Device Component	9	9
Material Discolored	8	8
Increase in Pressure	6	6
Contamination	6	6
Patient Device Interaction Problem	6	6
Unintended Movement	5	5
Therapeutic or Diagnostic Output Failure	5	5
Break	5	5
Device Contaminated During Manufacture or Shipping	5	5
Positioning Problem	4	4
Difficult to Open or Close	3	3
Expulsion	3	3
Difficult or Delayed Positioning	3	3
Device Markings/Labelling Problem	3	3
Material Erosion	3	3
Material Split, Cut or Torn	2	2
Component Missing	2	2
Delivered as Unsterile Product	2	2
Shipping Damage or Problem	2	2
Material Protrusion/Extrusion	2	2
Material Integrity Problem	2	2
Unsealed Device Packaging	2	2
Device Appears to Trigger Rejection	2	2
Connection Problem	2	2
Self-Activation or Keying	2	2
Collapse	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Urinary Incontinence	5676	5677
No Clinical Signs, Symptoms or Conditions	1927	1927
Unspecified Tissue Injury	1474	1474
Erosion	1313	1313
Incontinence	957	957
No Known Impact Or Consequence To Patient	562	562
Unspecified Infection	416	416
Urinary Retention	268	268
Tissue Damage	245	245
Pain	242	242
Insufficient Information	165	165
No Consequences Or Impact To Patient	132	132
Discomfort	118	118
Perforation	107	108
Swelling/ Edema	84	84
Dysuria	62	62
Hematuria	52	52
Inflammation	50	50
Scar Tissue	40	40
Urethral Stenosis/Stricture	39	39
Internal Organ Perforation	38	39
Hematoma	34	34
Urinary Tract Infection	31	31
Hemorrhage/Bleeding	25	25
Fever	22	22
Abscess	19	19
Fistula	18	18
Wound Dehiscence	18	18
Adhesion(s)	17	17
Fluid Discharge	17	17
Purulent Discharge	16	16
Hernia	15	15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
Implant Pain	12	12
Burning Sensation	11	11
Fibrosis	11	11
Capsular Contracture	10	10
Bacterial Infection	10	10
Swelling	10	10
Hypersensitivity/Allergic reaction	9	9
Erythema	9	9
Micturition Urgency	8	8
Obstruction/Occlusion	7	7
Necrosis	7	7
Abdominal Pain	7	7
Scarring	6	6
Post Operative Wound Infection	6	6
Stenosis	6	6
Anxiety	6	6
Failure of Implant	6	6

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