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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lubricant, patient
Product CodeKMJ
Regulation Number 880.6375
Device Class 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 1 1
2022 4 4
2023 4 4
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Patient-Device Incompatibility 2 2
Device Contamination with Chemical or Other Material 2 2
Use of Device Problem 1 1
Device Markings/Labelling Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 3 3
Unspecified Infection 2 2
Burning Sensation 2 2
Dizziness 1 1
No Consequences Or Impact To Patient 1 1
Anaphylactoid 1 1
Discomfort 1 1
Depression 1 1
Impaired Healing 1 1
Sore Throat 1 1
Low Oxygen Saturation 1 1
Shaking/Tremors 1 1
Caustic/Chemical Burns 1 1
Superficial (First Degree) Burn 1 1
Foreign Body In Patient 1 1
Angioedema 1 1
Blister 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Itching Sensation 1 1
Pain 1 1
Rash 1 1
Respiratory Distress 1 1
Skin Erosion 1 1
Swelling 1 1
Tachycardia 1 1
Urinary Tract Infection 1 1
Vaginal Mucosa Damage 1 1
Low Blood Pressure/ Hypotension 1 1
Adult Respiratory Distress Syndrome 1 1
Erythema 1 1
Foreign Body Reaction 1 1
Granuloma 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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