TPLC - Total Product Life Cycle

• 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

MDR Year	MDR Reports	MDR Events
2020	1743	1743
2021	1697	1697
2022	1553	1553
2023	1778	1779
2024	2110	2111
2025	2099	2099
2026	906	907

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	3710	3711
Mechanical Problem	2863	2864
Fluid/Blood Leak	2579	2580
Insufficient Device Problem Information	1615	1615
Material Puncture/Hole	1392	1393
Inadequacy of Device Shape and/or Size	988	988
Migration	415	415
Defective Device	366	366
Malposition of Device	255	255
Inflation Problem	180	180
Decrease in Pressure	139	139
Air/Gas in Device	74	74
Nonstandard Device	58	58
Difficult or Delayed Activation	55	55
Disconnection	53	53
Deflation Problem	40	40
Use of Device Problem	39	40
Failure to Cycle	28	28
Material Deformation	23	23
Device Contamination with Chemical or Other Material	21	21
Improper or Incorrect Procedure or Method	14	15
Human-Device Interface Problem	14	14
Detachment of Device or Device Component	13	13
Device Remains Activated	11	11
Migration or Expulsion of Device	9	9
Material Discolored	8	8
Patient Device Interaction Problem	6	6
Increase in Pressure	6	6
Contamination	6	6
Device Contaminated During Manufacture or Shipping	5	5
Unintended Movement	5	5
Positioning Problem	4	4
Expulsion	4	4
Break	4	4
Difficult or Delayed Positioning	3	3
Device Markings/Labelling Problem	3	3
Material Integrity Problem	2	2
Unsealed Device Packaging	2	2
Component Missing	2	2
Collapse	2	2
Device Appears to Trigger Rejection	2	2
Loose or Intermittent Connection	2	2
Delivered as Unsterile Product	2	2
Device Damaged Prior to Receipt by User	2	2
Connection Problem	2	2
Material Split, Cut or Torn	2	2
Self-Activation or Keying	2	2
Therapeutic or Diagnostic Output Failure	2	2
Difficult to Open or Close	2	2
Pressure Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Urinary Incontinence	6013	6014
No Clinical Signs, Symptoms or Conditions	1991	1992
Unspecified Tissue Injury	1493	1493
Erosion	1363	1363
Incontinence	960	960
No Known Impact Or Consequence To Patient	562	562
Unspecified Infection	434	434
Urinary Retention	279	279
Pain	261	261
Tissue Damage	245	245
Insufficient Information	167	167
No Consequences Or Impact To Patient	132	132
Discomfort	121	121
Perforation	109	110
Swelling/ Edema	89	89
Muscle Weakness/Atrophy	69	69
Dysuria	67	67
Hematuria	56	56
Inflammation	51	51
Urethral Stenosis/Stricture	42	42
Scar Tissue	42	42
Internal Organ Perforation	38	39
Hematoma	35	35
Urinary Tract Infection	31	31
Hemorrhage/Blood Loss/Bleeding	28	28
Fever	24	24
Abscess	19	19
Wound Dehiscence	19	19
Fistula	18	18
Purulent Discharge	18	18
Adhesion(s)	17	17
Fluid Discharge	17	17
Hernia	16	16
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	14	14
Implant Pain	13	13
Erythema	12	12
Fibrosis	12	12
Bacterial Infection	12	12
Burning Sensation	11	11
Micturition Urgency	11	11
Swelling	10	10
Capsular Contracture	10	10
Hypersensitivity/Allergic reaction	9	9
Abdominal Pain	7	7
Necrosis	7	7
Obstruction/Occlusion	7	7
Failure of Implant	6	6
Scarring	6	6
Anxiety	6	6
Stenosis	6	6

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