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TPLC
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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
MDR Year
MDR Reports
MDR Events
2014
9
9
2015
13
13
2016
6
6
2017
9
9
2018
873
873
2019
2753
2753
2020
1742
1742
2021
1697
1697
2022
1553
1553
2023
1778
1778
2024
1397
1397
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 Remains Activated
11
11
Device Operates Differently Than Expected
11
11
Material Erosion
10
10
Leak/Splash
7
7
Material Discolored
6
6
Contamination
6
6
Gas/Air Leak
5
5
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
Unstable
5
5
Expulsion
5
5
Positioning Problem
4
4
Device Contaminated During Manufacture or Shipping
4
4
Connection Problem
4
4
Device Markings/Labelling Problem
3
3
Loose or Intermittent Connection
3
3
Material Rupture
3
3
Material Protrusion/Extrusion
2
2
Therapeutic or Diagnostic Output Failure
2
2
Material Integrity Problem
2
2
Unintended Movement
2
2
Extrusion
2
2
Shipping Damage or Problem
2
2
Component Missing
2
2
Lack of Effect
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
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