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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
1
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
714
714
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
3668
3668
Fluid/Blood Leak
2192
2192
Adverse Event Without Identified Device or Use Problem
2113
2113
Mechanical Problem
2096
2096
Material Puncture/Hole
1118
1118
Inadequacy of Device Shape and/or Size
831
831
Defective Device
347
347
Migration
331
331
Malposition of Device
207
207
Inflation Problem
151
151
Decrease in Pressure
102
102
Failure to Cycle
79
79
Difficult or Delayed Activation
42
42
Use of Device Problem
37
37
Deflation Problem
31
31
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
15
15
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
Unintended Movement
2
2
Material Integrity Problem
2
2
Material Protrusion/Extrusion
2
2
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
3112
3112
Incontinence
2280
2280
No Known Impact Or Consequence To Patient
2111
2111
Erosion
1267
1267
No Clinical Signs, Symptoms or Conditions
1232
1232
Unspecified Tissue Injury
905
905
Tissue Damage
621
621
Unspecified Infection
447
447
No Consequences Or Impact To Patient
297
297
Urinary Retention
238
238
Pain
196
196
Insufficient Information
139
139
Perforation
116
116
Discomfort
87
87
Dysuria
55
55
Swelling/ Edema
49
49
Inflammation
40
40
Hematuria
38
38
Hematoma
34
34
Urinary Tract Infection
30
30
Scar Tissue
29
29
Complaint, Ill-Defined
29
29
Internal Organ Perforation
26
26
Swelling
24
24
Fistula
21
21
Urethral Stenosis/Stricture
21
21
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
Obstruction/Occlusion
12
12
No Code Available
12
12
Capsular Contracture
11
11
Purulent Discharge
11
11
Stenosis
9
9
Fibrosis
9
9
Implant Pain
9
9
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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