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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
2021 40 40
2022 9 9
2023 29 29
2024 11 11
2025 14 14
2026 50 50

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Component 35 35
Device Markings/Labelling Problem 25 25
Adverse Event Without Identified Device or Use Problem 23 23
Device Contamination with Chemical or Other Material 18 18
Nonstandard Device 13 13
Contamination 9 9
Missing Information 7 7
Component Missing 4 4
Patient Device Interaction Problem 3 3
Patient-Device Incompatibility 2 2
Microbial Contamination of Device 2 2
Contamination of Device Ingredient or Reagent 2 2
Illegible Information 2 2
Unexpected Therapeutic Results 2 2
Device-Device Incompatibility 1 1
Insufficient Information 1 1
Expiration Date Error 1 1
Defective Device 1 1
Degraded 1 1
Material Discolored 1 1
Product Quality Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Inaccurate Information 1 1
Improper Chemical Reaction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 114 114
Unspecified Infection 13 13
Fatigue 7 7
Rash 6 6
Skin Inflammation/ Irritation 5 5
Swelling/ Edema 5 5
Skin Infection 4 4
Nausea 4 4
Sepsis 4 4
No Consequences Or Impact To Patient 4 4
Fever 4 4
Chills 4 4
Abscess 4 4
Low Blood Pressure/ Hypotension 3 3
Erythema 3 3
Insufficient Information 3 3
Decreased Appetite 2 2
Skin Burning Sensation 2 2
Bruise/Contusion 2 2
Tissue Breakdown 2 2
Unspecified Vascular Problem 2 2
Loss of consciousness 2 2
Hot Flashes/Flushes 2 2
Hemorrhage/Bleeding 2 2
Headache 2 2
Bacterial Infection 2 2
Pain 2 2
Vomiting 2 2
Diarrhea 2 2
Osteomyelitis 2 2
Neck Pain 2 2
Paralysis 2 2
Epistaxis 2 2
Local Reaction 2 2
Purulent Discharge 2 2
Anemia 2 2
Necrosis 2 2
Dehydration 1 1
Cough 1 1
Ulcer 1 1
Post Traumatic Wound Infection 1 1
Muscle Weakness 1 1
Speech Disorder 1 1
Hypersensitivity/Allergic reaction 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
High Blood Pressure/ Hypertension 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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