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TPLC
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show TPLC since
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2024
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Device
bandage, liquid
Product Code
KMF
Regulation Number
880.5090
Device Class
1
Premarket Reviews
Manufacturer
Decision
ALEO BME INC.
SUBSTANTIALLY EQUIVALENT
1
ROCHAL INDUSTRIES, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
10
10
2019
6
6
2020
8
8
2021
10
10
2022
7
7
2023
6
6
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fire
16
16
Adverse Event Without Identified Device or Use Problem
13
13
Improper or Incorrect Procedure or Method
4
4
Compatibility Problem
2
2
Appropriate Term/Code Not Available
2
2
Patient Device Interaction Problem
2
2
Patient-Device Incompatibility
2
2
Contamination /Decontamination Problem
2
2
Device Operates Differently Than Expected
1
1
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
Inadequate or Insufficient Training
1
1
Use of Device Problem
1
1
Inadequate Lubrication
1
1
Insufficient Information
1
1
Mechanical Jam
1
1
Defective Component
1
1
Sparking
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Erythema
6
6
Rash
6
6
No Known Impact Or Consequence To Patient
5
5
Skin Inflammation/ Irritation
5
5
No Clinical Signs, Symptoms or Conditions
4
4
Superficial (First Degree) Burn
4
4
Unspecified Infection
4
4
Hypersensitivity/Allergic reaction
3
3
Burn(s)
3
3
No Consequences Or Impact To Patient
3
3
Blister
3
3
Fungal Infection
2
2
Not Applicable
2
2
Swelling/ Edema
2
2
Insufficient Information
2
2
Hemorrhage/Bleeding
2
2
Pain
2
2
Itching Sensation
1
1
Abrasion
1
1
Anaphylactoid
1
1
Discharge
1
1
Coma
1
1
Sepsis
1
1
Skin Discoloration
1
1
Skin Erosion
1
1
Skin Irritation
1
1
Swelling
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Contact Dermatitis
1
1
Skin Inflammation
1
1
Skin Tears
1
1
Patient Problem/Medical Problem
1
1
Skin Burning Sensation
1
1
Skin Infection
1
1
Full thickness (Third Degree) Burn
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
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