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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
0
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
521
521
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
3645
3645
Fluid/Blood Leak
2137
2137
Adverse Event Without Identified Device or Use Problem
2052
2052
Mechanical Problem
2048
2048
Material Puncture/Hole
1096
1096
Inadequacy of Device Shape and/or Size
813
813
Defective Device
341
341
Migration
326
326
Malposition of Device
202
202
Inflation Problem
149
149
Decrease in Pressure
98
98
Failure to Cycle
79
79
Difficult or Delayed Activation
42
42
Use of Device Problem
37
37
Deflation Problem
30
30
Disconnection
30
30
Material Deformation
26
26
Air/Gas in Device
26
26
Appropriate Term/Code Not Available
21
21
Device Contamination with Chemical or Other Material
14
14
Improper or Incorrect Procedure or Method
12
12
Device Remains Activated
11
11
Migration or Expulsion of Device
11
11
Device Operates Differently Than Expected
11
11
Material Erosion
10
10
Leak/Splash
7
7
Material Discolored
6
6
Contamination
6
6
Break
5
5
Self-Activation or Keying
5
5
Increase in Pressure
5
5
Unstable
5
5
Gas/Air Leak
5
5
Detachment of Device or Device Component
5
5
Expulsion
5
5
Connection Problem
4
4
Patient Device Interaction Problem
4
4
Device Contaminated During Manufacture or Shipping
4
4
Positioning Problem
3
3
Device Markings/Labelling Problem
3
3
Material Rupture
3
3
Loose or Intermittent Connection
3
3
Shipping Damage or Problem
2
2
Extrusion
2
2
Therapeutic or Diagnostic Output Failure
2
2
Material Integrity Problem
2
2
Material Protrusion/Extrusion
2
2
Unintended Movement
1
1
Pressure Problem
1
1
Material Split, Cut or Torn
1
1
Activation Problem
1
1
Lack of Effect
1
1
Wrong Label
1
1
Human-Device Interface Problem
1
1
Free or Unrestricted Flow
1
1
Activation, Positioning or Separation Problem
1
1
Device Damaged by Another Device
1
1
Device-Device Incompatibility
1
1
Device Dislodged or Dislocated
1
1
Product Quality Problem
1
1
Premature Discharge of Battery
1
1
Stretched
1
1
Device Inoperable
1
1
Material Perforation
1
1
Component Missing
1
1
Fracture
1
1
Hole In Material
1
1
Delivered as Unsterile Product
1
1
No Device Output
1
1
Collapse
1
1
Corroded
1
1
Crack
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Urinary Incontinence
2973
2973
Incontinence
2279
2279
No Known Impact Or Consequence To Patient
2111
2111
Erosion
1248
1248
No Clinical Signs, Symptoms or Conditions
1202
1202
Unspecified Tissue Injury
880
880
Tissue Damage
621
621
Unspecified Infection
437
437
No Consequences Or Impact To Patient
297
297
Urinary Retention
233
233
Pain
192
192
Insufficient Information
136
136
Perforation
114
114
Discomfort
86
86
Dysuria
55
55
Swelling/ Edema
47
47
Inflammation
38
38
Hematuria
37
37
Hematoma
33
33
Urinary Tract Infection
29
29
Complaint, Ill-Defined
29
29
Scar Tissue
28
28
Internal Organ Perforation
26
26
Swelling
24
24
Fistula
21
21
Urethral Stenosis/Stricture
20
20
Injury
19
19
Hemorrhage/Bleeding
19
19
Wound Dehiscence
18
18
Adhesion(s)
18
18
Abscess
17
17
Fluid Discharge
16
16
Scarring
15
15
Fever
14
14
Failure of Implant
12
12
No Code Available
12
12
Obstruction/Occlusion
11
11
Capsular Contracture
11
11
Purulent Discharge
10
10
Stenosis
9
9
Implant Pain
9
9
Fibrosis
8
8
Hernia
8
8
Burning Sensation
8
8
Hypersensitivity/Allergic reaction
8
8
Bacterial Infection
8
8
Abdominal Pain
7
7
Micturition Urgency
7
7
Thrombosis
7
7
Necrosis
6
6
Sepsis
6
6
Cellulitis
6
6
Anxiety
6
6
No Information
6
6
No Patient Involvement
5
5
Post Operative Wound Infection
5
5
Foreign Body In Patient
4
4
Urinary Frequency
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Calcium Deposits/Calcification
4
4
Edema
4
4
Irritation
4
4
Muscle Weakness
4
4
Renal Failure
3
3
Itching Sensation
3
3
Death
3
3
Pulmonary Embolism
3
3
Impaired Healing
3
3
Unspecified Kidney or Urinary Problem
3
3
Cramp(s) /Muscle Spasm(s)
3
3
Patient Problem/Medical Problem
2
2
Bruise/Contusion
2
2
Extravasation
2
2
Staphylococcus Aureus
2
2
Perforation of Vessels
2
2
Pneumonia
2
2
Pocket Erosion
2
2
Rash
2
2
Seroma
1
1
Myocardial Infarction
1
1
Nerve Damage
1
1
Neuropathy
1
1
Occlusion
1
1
Electrolyte Imbalance
1
1
Therapeutic Response, Decreased
1
1
Ulcer
1
1
Rupture
1
1
Tachycardia
1
1
Therapeutic Effects, Unexpected
1
1
Ulceration
1
1
Fatigue
1
1
Erythema
1
1
Headache
1
1
Foreign Body Reaction
1
1
Laceration(s)
1
1
Muscle Spasm(s)
1
1
Hypoxia
1
1
Dehydration
1
1
Cardiac Arrest
1
1
Air Embolism
1
1
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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