TPLC - Total Product Life Cycle

• 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
Adverse Event Without Identified Device or Use Problem	1	1
Appropriate Term/Code Not Available	1	1
Missing Information	1	1
Defective Device	1	1
Patient-Device Incompatibility	1	1
Defective Component	1	1
Component Missing	1	1
Contamination	1	1
Restricted Flow rate	1	1
Kinked	1	1
Occlusion Within Device	1	1
No Device Output	1	1
Use of Device Problem	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
Insufficient Information	1	1
No Clinical Signs, Symptoms or Conditions	1	1
Abrasion	1	1
Exposure to Body Fluids	1	1
Burn(s)	1	1
Erythema	1	1
Pain	1	1
Scarring	1	1
Sepsis	1	1
Skin Irritation	1	1
Urinary Tract Infection	1	1
No Consequences Or Impact To Patient	1	1
Anaphylactoid	1	1
Ulcer	1	1
Pressure Sores	1	1
Injury	1	1
Reaction	1	1
Numbness	1	1
Needle Stick/Puncture	1	1
Hematuria	1	1
Alteration In Body Temperature	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Coloplast Manufacturing US, LLC	II	Oct-30-2014
2	Purewick Corporation	II	Mar-06-2017