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
10	3	6	4	3	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	3245	3245
Mechanical Problem	2536	2536
Fluid/Blood Leak	2303	2303
Insufficient Information	1536	1536
Material Puncture/Hole	1249	1249
Inadequacy of Device Shape and/or Size	865	865
Migration	371	371
Defective Device	370	370
Malposition of Device	238	238
Inflation Problem	162	162
Decrease in Pressure	111	111
Air/Gas in Device	56	56
Difficult or Delayed Activation	49	49
Disconnection	44	44
Deflation Problem	39	39
Use of Device Problem	35	35
Failure to Cycle	29	29
Material Deformation	21	21
Device Contamination with Chemical or Other Material	19	19
Improper or Incorrect Procedure or Method	14	14
Device Remains Activated	11	11
Migration or Expulsion of Device	10	10
Detachment of Device or Device Component	8	8
Material Discolored	7	7
Increase in Pressure	6	6
Patient Device Interaction Problem	6	6
Contamination	6	6
Unintended Movement	5	5
Device Contaminated During Manufacture or Shipping	5	5
Break	5	5
Positioning Problem	4	4
Therapeutic or Diagnostic Output Failure	3	3
Difficult to Open or Close	3	3
Human-Device Interface Problem	3	3
Material Erosion	3	3
Device Markings/Labelling Problem	3	3
Leak/Splash	2	2
Expulsion	2	2
Loose or Intermittent Connection	2	2
Self-Activation or Keying	2	2
Device Appears to Trigger Rejection	2	2
Material Protrusion/Extrusion	2	2
Delivered as Unsterile Product	2	2
Collapse	2	2
Difficult or Delayed Positioning	2	2
Component Missing	2	2
Unsealed Device Packaging	2	2
Material Integrity Problem	2	2
Shipping Damage or Problem	2	2
Material Rupture	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Urinary Incontinence	5108	5108
No Clinical Signs, Symptoms or Conditions	1813	1813
Unspecified Tissue Injury	1345	1345
Erosion	1236	1236
Incontinence	955	955
No Known Impact Or Consequence To Patient	562	562
Unspecified Infection	396	396
Urinary Retention	254	254
Tissue Damage	245	245
Pain	225	225
Insufficient Information	154	154
No Consequences Or Impact To Patient	132	132
Discomfort	114	114
Perforation	103	103
Swelling/ Edema	80	80
Dysuria	57	57
Hematuria	49	49
Inflammation	47	47
Scar Tissue	38	38
Internal Organ Perforation	37	37
Urethral Stenosis/Stricture	32	32
Hematoma	32	32
Urinary Tract Infection	28	28
Hemorrhage/Bleeding	23	23
Fever	21	21
Abscess	19	19
Adhesion(s)	17	17
Wound Dehiscence	17	17
Fistula	17	17
Fluid Discharge	16	16
Purulent Discharge	16	16
Hernia	14	14
Implant Pain	12	12
Burning Sensation	11	11
Capsular Contracture	10	10
Swelling	10	10
Fibrosis	10	10
Bacterial Infection	9	9
Hypersensitivity/Allergic reaction	8	8
Erythema	8	8
Micturition Urgency	7	7
Abdominal Pain	7	7
Necrosis	7	7
Obstruction/Occlusion	7	7
Post Operative Wound Infection	6	6
Failure of Implant	6	6
Anxiety	6	6
Scarring	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Urinary Frequency	5	5

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