Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
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 Back to Search Results
Device device, incontinence, urosheath type, non-sterile
Regulation Description Urine collector and accessories.
Definition Urine collector and accessories; see product code EXJ
Product CodeNNX
Regulation Number 876.5250
Device Class 1

MDR Year MDR Reports MDR Events
2020 180 180
2021 148 148
2022 111 111
2023 44 44
2024 10 10
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Nonstandard Device 323 323
Difficult to Remove 48 48
Biocompatibility 43 43
Adverse Event Without Identified Device or Use Problem 41 41
Physical Resistance/Sticking 27 27
Loss of or Failure to Bond 12 12
Patient Device Interaction Problem 12 12
Material Deformation 8 8
Patient-Device Incompatibility 7 7
Missing Information 7 7
Inadequacy of Device Shape and/or Size 7 7
Inadequate Instructions for Healthcare Professional 7 7
Component Missing 6 6
Product Quality Problem 5 5
Device Handling Problem 5 5
Therapeutic or Diagnostic Output Failure 5 5
Inaccurate Flow Rate 5 5
Leak/Splash 4 4
Fluid/Blood Leak 4 4
Inadequate or Insufficient Training 4 4
Expiration Date Error 4 4
Use of Device Problem 4 4
Material Twisted/Bent 4 4
Illegible Information 3 3
Component Misassembled 3 3
Sharp Edges 3 3
Material Too Rigid or Stiff 3 3
Material Integrity Problem 3 3
Defective Device 3 3
Obstruction of Flow 2 2
Backflow 2 2
Labelling, Instructions for Use or Training Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Detachment of Device or Device Component 2 2
Defective Component 2 2
Device Markings/Labelling Problem 2 2
Deformation Due to Compressive Stress 2 2
Restricted Flow rate 2 2
Improper Flow or Infusion 1 1
Decrease in Pressure 1 1
Structural Problem 1 1
Partial Blockage 1 1
Device Contamination with Chemical or Other Material 1 1
No Apparent Adverse Event 1 1
Wrong Label 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Unintended Movement 1 1
Material Too Soft/Flexible 1 1
Difficult to Open or Close 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 183 183
No Consequences Or Impact To Patient 114 114
Urinary Tract Infection 53 53
No Known Impact Or Consequence To Patient 52 52
Pain 50 50
Skin Inflammation/ Irritation 43 43
Skin Tears 36 36
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 29 29
Unspecified Infection 18 18
Tissue Breakdown 13 13
Patient Problem/Medical Problem 11 11
Irritation 9 9
Pressure Sores 8 8
No Code Available 8 8
Discomfort 8 8
Skin Discoloration 6 6
Hemorrhage/Bleeding 5 5
Abrasion 5 5
Injury 4 4
Rash 4 4
Skin Irritation 4 4
Swelling/ Edema 3 3
Hypersensitivity/Allergic reaction 3 3
Blood Loss 2 2
Insufficient Information 2 2
No Information 2 2
Bacterial Infection 2 2
Hematuria 2 2
Fever 1 1
Localized Skin Lesion 1 1
Blister 1 1
Erythema 1 1
Swelling 1 1
Local Reaction 1 1
No Patient Involvement 1 1
Laceration(s) 1 1
Adhesion(s) 1 1
Reaction 1 1
Contact Dermatitis 1 1
Tissue Damage 1 1
Fungal Infection 1 1
Irritability 1 1
Complaint, Ill-Defined 1 1
Bruise/Contusion 1 1

-
-