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	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	3405	3406
Mechanical Problem	2556	2556
Fluid/Blood Leak	2246	2247
Material Puncture/Hole	1256	1256
Inadequacy of Device Shape and/or Size	869	869
Insufficient Information	869	869
Migration	358	358
Defective Device	319	319
Malposition of Device	230	230
Inflation Problem	163	163
Decrease in Pressure	125	125
Air/Gas in Device	71	71
Difficult or Delayed Activation	54	54
Disconnection	53	53
Nonstandard Device	47	47
Deflation Problem	38	38
Use of Device Problem	37	38
Device Contamination with Chemical or Other Material	20	20
Improper or Incorrect Procedure or Method	14	15
Material Deformation	14	14
Human-Device Interface Problem	13	13
Device Remains Activated	9	9
Detachment of Device or Device Component	9	9
Migration or Expulsion of Device	8	8
Material Discolored	7	7
Increase in Pressure	6	6
Therapeutic or Diagnostic Output Failure	6	6
Patient Device Interaction Problem	6	6
Unintended Movement	5	5
Positioning Problem	4	4
Difficult to Open or Close	3	3
Difficult or Delayed Positioning	3	3
Contamination	3	3
Break	3	3
Unsealed Device Packaging	2	2
Material Rupture	2	2
Material Erosion	2	2
Collapse	2	2
Material Split, Cut or Torn	2	2
Device Appears to Trigger Rejection	2	2
Connection Problem	2	2
Self-Activation or Keying	2	2
Device Contaminated During Manufacture or Shipping	2	2
Expulsion	2	2
Shipping Damage or Problem	1	1
Microbial Contamination of Device	1	1
Component Missing	1	1
Material Integrity Problem	1	1
Device Damaged by Another Device	1	1
Infusion or Flow Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Urinary Incontinence	5882	5883
No Clinical Signs, Symptoms or Conditions	1968	1968
Unspecified Tissue Injury	1489	1489
Erosion	1143	1143
Unspecified Infection	342	342
Urinary Retention	239	239
Pain	215	215
Incontinence	194	194
Insufficient Information	161	161
Discomfort	105	105
Perforation	89	90
Swelling/ Edema	84	84
Hematuria	52	52
Dysuria	50	50
Inflammation	44	44
Urethral Stenosis/Stricture	40	40
Muscle Weakness	40	40
Internal Organ Perforation	36	37
Scar Tissue	36	36
Hematoma	30	30
Urinary Tract Infection	26	26
Hemorrhage/Bleeding	25	25
Fever	19	19
Abscess	18	18
No Known Impact Or Consequence To Patient	17	17
Wound Dehiscence	16	16
Tissue Damage	15	15
Hernia	15	15
Adhesion(s)	14	14
Purulent Discharge	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
Implant Pain	13	13
Fluid Discharge	12	12
Fistula	12	12
Fibrosis	11	11
Erythema	11	11
Capsular Contracture	9	9
No Consequences Or Impact To Patient	9	9
Burning Sensation	8	8
Micturition Urgency	8	8
Necrosis	7	7
Bacterial Infection	7	7
Hypersensitivity/Allergic reaction	7	7
Failure of Implant	6	6
Anxiety	6	6
Post Operative Wound Infection	6	6
Abdominal Pain	6	6
Foreign Body In Patient	5	5
Obstruction/Occlusion	5	5
Unspecified Kidney or Urinary Problem	4	4

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