TPLC - Total Product Life Cycle

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Device	device, incontinence, mechanical/hydraulic
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)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
7	6	4	8	2	4	9	14	12	12	10	10	3	6	4	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	3730	3730
Adverse Event Without Identified Device or Use Problem	2361	2361
Fluid/Blood Leak	2336	2336
Mechanical Problem	2222	2222
Material Puncture/Hole	1183	1183
Inadequacy of Device Shape and/or Size	885	885
Defective Device	375	375
Migration	358	358
Malposition of Device	226	226
Inflation Problem	153	153
Decrease in Pressure	112	112
Failure to Cycle	79	79
Difficult or Delayed Activation	47	47
Use of Device Problem	39	39
Disconnection	34	34
Deflation Problem	32	32
Air/Gas in Device	31	31
Material Deformation	27	27
Appropriate Term/Code Not Available	22	22
Device Contamination with Chemical or Other Material	16	16
Improper or Incorrect Procedure or Method	15	15
Migration or Expulsion of Device	13	13
Device Operates Differently Than Expected	11	11
Device Remains Activated	11	11
Material Erosion	10	10
Leak/Splash	7	7
Contamination	6	6
Material Discolored	6	6
Break	5	5
Self-Activation or Keying	5	5
Increase in Pressure	5	5
Patient Device Interaction Problem	5	5
Detachment of Device or Device Component	5	5
Expulsion	5	5
Unstable	5	5
Gas/Air Leak	5	5
Connection Problem	4	4
Positioning Problem	4	4
Device Contaminated During Manufacture or Shipping	4	4
Device Markings/Labelling Problem	3	3
Loose or Intermittent Connection	3	3
Material Rupture	3	3
Material Protrusion/Extrusion	2	2
Component Missing	2	2
Shipping Damage or Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Material Integrity Problem	2	2
Unintended Movement	2	2
Extrusion	2	2
Infusion or Flow Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Urinary Incontinence	3499	3499
Incontinence	2320	2320
No Known Impact Or Consequence To Patient	2111	2111
No Clinical Signs, Symptoms or Conditions	1378	1378
Erosion	1348	1348
Unspecified Tissue Injury	992	992
Tissue Damage	621	621
Unspecified Infection	466	466
No Consequences Or Impact To Patient	297	297
Urinary Retention	259	259
Pain	206	206
Insufficient Information	148	148
Perforation	125	125
Discomfort	96	96
Dysuria	59	59
Swelling/ Edema	56	56
Hematuria	41	41
Inflammation	41	41
Hematoma	36	36
Urinary Tract Infection	31	31
Internal Organ Perforation	31	31
Scar Tissue	30	30
Complaint, Ill-Defined	29	29
Swelling	24	24
Fistula	22	22
Hemorrhage/Bleeding	22	22
Urethral Stenosis/Stricture	21	21
Wound Dehiscence	19	19
Fever	19	19
Injury	19	19
Adhesion(s)	18	18
Abscess	18	18
Fluid Discharge	16	16
Scarring	15	15
Obstruction/Occlusion	13	13
No Code Available	12	12
Failure of Implant	12	12
Capsular Contracture	11	11
Purulent Discharge	11	11
Implant Pain	10	10
Fibrosis	9	9
Bacterial Infection	9	9
Stenosis	9	9
Burning Sensation	9	9
Hypersensitivity/Allergic reaction	8	8
Hernia	8	8
Abdominal Pain	7	7
Micturition Urgency	7	7
Thrombosis	7	7
Anxiety	6	6

Recalls
Manufacturer		Recall Class	Date Posted
1	American Medical Systems, Inc.	II	May-10-2013
2	American Medical Systems, Inc.	II	Jun-27-2011
3	Boston Scientific Corporation	II	Aug-30-2019
4	Uromedica Inc.	II	Jan-05-2022