TPLC - Total Product Life Cycle

• Device: lubricant, patient
• Regulation Description: Patient lubricant.
• Product Code: KMJ
• Regulation Number: 880.6375
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2019	2	2
2020	1	1
2022	4	5
2023	4	4
2024	3	3
2025	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	5	6
Patient-Device Incompatibility	2	2
Device Contamination with Chemical or Other Material	2	2
Device Markings/Labelling Problem	1	1
Insufficient Information	1	1
Contamination /Decontamination Problem	1	1
Use of Device Problem	1	1
Missing 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	4
Unspecified Infection	2	2
No Clinical Signs, Symptoms or Conditions	2	2
Itching Sensation	2	3
Foreign Body Reaction	2	2
Burning Sensation	2	2
Granuloma	2	2
Impaired Healing	1	1
Superficial (First Degree) Burn	1	1
Adult Respiratory Distress Syndrome	1	2
Respiratory Distress	1	1
Dizziness	1	2
Anaphylactoid	1	1
Blister	1	1
Vaginal Mucosa Damage	1	1
Skin Erosion	1	1
Foreign Body In Patient	1	1
Erythema	1	1
Swelling	1	1
Depression	1	1
Pain	1	2
Tachycardia	1	2
Shaking/Tremors	1	2
Swelling/ Edema	1	1
Caustic/Chemical Burns	1	1
No Consequences Or Impact To Patient	1	1
Sore Throat	1	2
Low Blood Pressure/ Hypotension	1	2
Low Oxygen Saturation	1	2
Urinary Tract Infection	1	1
Angioedema	1	2

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