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 bandage, liquid
Product CodeKMF
Regulation Number 880.5090
Device Class 1


Premarket Reviews
ManufacturerDecision
OPTMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHAL INDUSTRIES, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 8 8
2021 10 10
2022 7 7
2023 6 6
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Fire 14 14
Adverse Event Without Identified Device or Use Problem 9 9
Improper or Incorrect Procedure or Method 5 5
Appropriate Term/Code Not Available 4 4
Patient Device Interaction Problem 2 2
Compatibility Problem 2 2
Contamination /Decontamination Problem 2 2
Device-Device Incompatibility 1 1
Difficult to Open or Remove Packaging Material 1 1
Improper Flow or Infusion 1 1
Loose or Intermittent Connection 1 1
Delivered as Unsterile Product 1 1
Off-Label Use 1 1
Mechanical Jam 1 1
Defective Component 1 1
Sparking 1 1
Inadequate Lubrication 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Inflammation/ Irritation 7 7
No Clinical Signs, Symptoms or Conditions 5 5
Rash 5 5
No Known Impact Or Consequence To Patient 4 4
Erythema 4 4
Superficial (First Degree) Burn 3 3
Hypersensitivity/Allergic reaction 3 3
Blister 3 3
Insufficient Information 3 3
No Consequences Or Impact To Patient 3 3
Unspecified Infection 2 2
Not Applicable 2 2
Burn(s) 2 2
Swelling/ Edema 2 2
Hemorrhage/Bleeding 2 2
Skin Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Sepsis 1 1
Fungal Infection 1 1
Anaphylactoid 1 1
Skin Discoloration 1 1
Pain 1 1
Coma 1 1
Contact Dermatitis 1 1
Skin Tears 1 1
Full thickness (Third Degree) Burn 1 1
Skin Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC II Mar-09-2020
2 Family Dollar Stores, Llc. II Aug-17-2022
-
-