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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pad, alcohol, device disinfectant
Product CodeLKB
Device Class Unclassified

MDR Year MDR Reports MDR Events
2019 37 37
2020 39 39
2021 40 40
2022 9 9
2023 29 29
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Device Markings/Labelling Problem 45 45
Device Contamination with Chemical or Other Material 39 39
Defective Component 34 34
Missing Information 7 7
Break 5 5
Accessory Incompatible 4 4
Contamination 3 3
Use of Device Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Entrapment of Device 2 2
Defective Device 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Component Missing 2 2
Product Quality Problem 2 2
Illegible Information 2 2
Leak/Splash 1 1
Chemical Problem 1 1
Device-Device Incompatibility 1 1
Physical Resistance/Sticking 1 1
Expiration Date Error 1 1
Contamination /Decontamination Problem 1 1
Material Fragmentation 1 1
Moisture or Humidity Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Dislodged or Dislocated 1 1
Fungus in Device Environment 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 78 78
No Known Impact Or Consequence To Patient 46 46
No Consequences Or Impact To Patient 15 15
No Patient Involvement 13 13
No Information 2 2
Insufficient Information 2 2
Unspecified Infection 1 1
Anaphylactoid 1 1
Blood Loss 1 1
Rash 1 1
Underdose 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
2 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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