Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
device, incontinence, urosheath type, non-sterile
Definition
Urine collector and accessories; see product code EXJ
Product Code
NNX
Regulation Number
876.5250
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
1
1
2016
12
12
2017
109
109
2018
147
147
2019
131
131
2020
180
180
2021
148
148
2022
111
111
2023
44
44
Device Problems
MDRs with this Device Problem
Events in those MDRs
Nonstandard Device
525
525
Difficult to Remove
144
144
Adverse Event Without Identified Device or Use Problem
57
57
Physical Resistance/Sticking
49
49
Material Integrity Problem
47
47
Biocompatibility
43
43
Device Operates Differently Than Expected
41
41
Sticking
33
33
Patient-Device Incompatibility
32
32
Product Quality Problem
30
30
Component Missing
18
18
Inadequate Instructions for Healthcare Professional
17
17
Material Deformation
15
15
Device Markings/Labelling Problem
13
13
Loss of or Failure to Bond
13
13
Defective Device
12
12
Inadequacy of Device Shape and/or Size
11
11
Inaccurate Flow Rate
11
11
Insufficient Information
11
11
Patient Device Interaction Problem
10
10
Material Too Rigid or Stiff
10
10
Appropriate Term/Code Not Available
8
8
Therapeutic or Diagnostic Output Failure
8
8
Missing Information
7
7
Leak/Splash
6
6
Failure To Adhere Or Bond
5
5
Labelling, Instructions for Use or Training Problem
5
5
Mechanical Problem
5
5
Expiration Date Error
5
5
Device Contamination with Chemical or Other Material
5
5
Material Twisted/Bent
5
5
Manufacturing, Packaging or Shipping Problem
5
5
Device Handling Problem
5
5
Structural Problem
4
4
Defective Component
4
4
Inadequate or Insufficient Training
4
4
Use of Device Problem
4
4
Improper or Incorrect Procedure or Method
4
4
Fluid/Blood Leak
4
4
Difficult to Fold, Unfold or Collapse
3
3
Backflow
3
3
Detachment Of Device Component
3
3
Shipping Damage or Problem
3
3
Output above Specifications
3
3
Detachment of Device or Device Component
3
3
Infusion or Flow Problem
3
3
Sharp Edges
3
3
Illegible Information
3
3
Component Misassembled
2
2
Physical Property Issue
2
2
No Flow
2
2
Output Problem
2
2
Improper Flow or Infusion
2
2
Inadequate Instructions for Non-Healthcare Professional
2
2
Incorrect Device Or Component Shipped
2
2
Deformation Due to Compressive Stress
2
2
Split
2
2
Obstruction of Flow
2
2
Fitting Problem
2
2
Incorrect Measurement
2
2
Restricted Flow rate
2
2
Accessory Incompatible
1
1
Hole In Material
1
1
Positioning Failure
1
1
Collapse
1
1
Partial Blockage
1
1
Bent
1
1
Material Rupture
1
1
Peeled/Delaminated
1
1
Decrease in Pressure
1
1
Retraction Problem
1
1
Occlusion Within Device
1
1
High Test Results
1
1
Out-Of-Box Failure
1
1
Incomplete or Missing Packaging
1
1
Device Contamination with Body Fluid
1
1
Separation Failure
1
1
Contamination /Decontamination Problem
1
1
Improper Chemical Reaction
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Difficult to Open or Close
1
1
Failure of Device to Self-Test
1
1
Packaging Problem
1
1
Measurement System Incompatibility
1
1
Pressure Problem
1
1
Unintended Movement
1
1
No Apparent Adverse Event
1
1
Material Too Soft/Flexible
1
1
Wrong Label
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
274
274
No Known Impact Or Consequence To Patient
225
225
No Clinical Signs, Symptoms or Conditions
181
181
Pain
92
92
Urinary Tract Infection
73
73
Skin Tears
58
58
Skin Inflammation/ Irritation
39
39
No Information
31
31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
28
28
No Patient Involvement
24
24
Discomfort
23
23
Skin Irritation
22
22
Unspecified Infection
21
21
Patient Problem/Medical Problem
15
15
No Code Available
15
15
Irritation
13
13
Injury
13
13
Pressure Sores
12
12
Tissue Breakdown
12
12
Abrasion
11
11
Skin Discoloration
9
9
Tissue Damage
9
9
Hemorrhage/Bleeding
8
8
Erythema
7
7
Bruise/Contusion
7
7
Rash
7
7
Swelling
5
5
Blood Loss
5
5
Urinary Retention
4
4
Hypersensitivity/Allergic reaction
4
4
Laceration(s)
3
3
Reaction
3
3
Foreign Body In Patient
3
3
Hematuria
3
3
Complaint, Ill-Defined
2
2
Swelling/ Edema
2
2
Insufficient Information
2
2
Excessive Tear Production
2
2
Burning Sensation
2
2
Adhesion(s)
2
2
Peeling
2
2
Itching Sensation
2
2
Inflammation
1
1
Local Reaction
1
1
Cyanosis
1
1
Edema
1
1
Incontinence
1
1
Fever
1
1
Head Injury
1
1
Skin Erosion
1
1
Ulcer
1
1
Fungal Infection
1
1
Irritability
1
1
Blister
1
1
Localized Skin Lesion
1
1
-
-