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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device pad, alcohol, device disinfectant
Product CodeLKB
Device Class Unclassified

MDR Year MDR Reports MDR Events
2021 40 40
2022 9 9
2023 29 29
2024 11 11
2025 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Component 35 35
Device Markings/Labelling Problem 24 24
Device Contamination with Chemical or Other Material 17 17
Missing Information 7 7
Contamination 3 3
Component Missing 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Illegible Information 2 2
Device-Device Incompatibility 1 1
Expiration Date Error 1 1
Degraded 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 95 95
No Consequences Or Impact To Patient 4 4
Unspecified Infection 2 2
Insufficient Information 2 2
Skin Inflammation/ Irritation 1 1
Local Reaction 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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