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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
2020 39 39
2021 40 40
2022 9 9
2023 29 29
2024 11 11
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Device Markings/Labelling Problem 44 44
Defective Component 32 32
Device Contamination with Chemical or Other Material 30 30
Missing Information 7 7
Contamination 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Illegible Information 2 2
Device-Device Incompatibility 1 1
Break 1 1
Entrapment of Device 1 1
Expiration Date Error 1 1
Defective Device 1 1
Contamination /Decontamination Problem 1 1
Use of Device Problem 1 1
Component Missing 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 88 88
No Known Impact Or Consequence To Patient 18 18
No Patient Involvement 13 13
No Consequences Or Impact To Patient 11 11
Unspecified Infection 2 2
Insufficient Information 2 2
Skin Inflammation/ Irritation 1 1
Local Reaction 1 1
Rash 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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