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
bag, urine collection, leg, for external use, non-sterile
Definition
Urine collector and accessories; see product code FAQ.
Product Code
NNW
Regulation Number
876.5250
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
2
2
2016
4
4
2017
4
4
2018
4
4
2020
1
1
2021
1
1
2022
1
1
2023
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
4
4
Improper or Incorrect Procedure or Method
3
3
Obstruction of Flow
2
2
Device Operates Differently Than Expected
2
2
Material Twisted/Bent
1
1
Component Missing
1
1
Use of Device Problem
1
1
Occlusion Within Device
1
1
Missing Information
1
1
Restricted Flow rate
1
1
Patient-Device Incompatibility
1
1
Kinked
1
1
Contamination
1
1
No Device Output
1
1
Defective Component
1
1
Defective Device
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Appropriate Term/Code Not Available
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Information
4
4
No Known Impact Or Consequence To Patient
2
2
Sepsis
1
1
Skin Irritation
1
1
No Clinical Signs, Symptoms or Conditions
1
1
Hematuria
1
1
Scarring
1
1
Abrasion
1
1
Anaphylactoid
1
1
Alteration In Body Temperature
1
1
Needle Stick/Puncture
1
1
Burn(s)
1
1
Injury
1
1
Exposure to Body Fluids
1
1
Numbness
1
1
Erythema
1
1
Insufficient Information
1
1
Pain
1
1
Reaction
1
1
Ulcer
1
1
Pressure Sores
1
1
No Consequences Or Impact To Patient
1
1
Urinary Tract Infection
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Coloplast Manufacturing US, LLC
II
Oct-30-2014
2
Purewick Corporation
II
Mar-06-2017
-
-