TPLC - Total Product Life Cycle

• Device: bandage, liquid, skin protectant
• Regulation Description: Liquid bandage.
• Product Code: NEC
• Regulation Number: 880.5090
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2020	5	5
2021	7	7
2022	5	5
2024	8	8
2025	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	6	6
Patient Device Interaction Problem	5	5
Off-Label Use	4	4
Fire	2	2
Device Handling Problem	2	2
Leak/Splash	1	1
Device Damaged Prior to Use	1	1
Unsealed Device Packaging	1	1
Therapeutic or Diagnostic Output Failure	1	1
Difficult to Remove	1	1
Flare or Flash	1	1
Device Emits Odor	1	1
Product Quality Problem	1	1
Appropriate Term/Code Not Available	1	1
Nonstandard Device	1	1
Improper or Incorrect Procedure or Method	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5	5
Skin Inflammation/ Irritation	5	5
Wound Dehiscence	4	4
Itching Sensation	3	3
Burn(s)	3	3
Unspecified Infection	2	2
Rash	2	2
Swelling/ Edema	2	2
Skin Tears	2	2
Skin Burning Sensation	2	2
Superficial (First Degree) Burn	1	1
Dysphasia	1	1
Sleep Dysfunction	1	1
Skin Irritation	1	1
Local Reaction	1	1
Blister	1	1
Localized Skin Lesion	1	1
No Known Impact Or Consequence To Patient	1	1
Burning Sensation	1	1
Discomfort	1	1
Insufficient Information	1	1
Erythema	1	1
Vomiting	1	1
Pain	1	1
Reaction	1	1
Cough	1	1
Dysphagia/ Odynophagia	1	1
Caustic/Chemical Burns	1	1
Partial thickness (Second Degree) Burn	1	1
Blurred Vision	1	1
Urinary Tract Infection	1	1