TPLC - Total Product Life Cycle

• Device: tape and bandage, adhesive
• Regulation Description: Medical adhesive tape and adhesive bandage.
• Product Code: KGX
• Regulation Number: 880.5240
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2021	562	567
2022	253	260
2023	192	195
2024	224	236
2025	323	400
2026	110	116

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	612	617
Loss of or Failure to Bond	243	259
Patient Device Interaction Problem	108	111
Patient-Device Incompatibility	80	84
Biocompatibility	61	64
Contamination /Decontamination Problem	49	49
Use of Device Problem	43	43
Material Integrity Problem	41	41
Delivered as Unsterile Product	38	39
Insufficient Information	23	23
Difficult to Open or Close	18	94
Nonstandard Device	18	18
Packaging Problem	18	18
Difficult to Remove	15	15
Material Separation	14	14
Physical Resistance/Sticking	14	14
Output Problem	13	16
Unsealed Device Packaging	13	14
Appropriate Term/Code Not Available	12	12
Difficult to Open or Remove Packaging Material	12	12
Contamination	11	11
Adhesive Too Strong	10	10
Product Quality Problem	9	9
Device Contaminated During Manufacture or Shipping	8	8
Peeled/Delaminated	8	8
Detachment of Device or Device Component	7	7
Defective Device	7	7
Separation Problem	7	7
Leak/Splash	6	6
Moisture Damage	6	6
Device Contamination with Chemical or Other Material	6	6
Failure to Obtain Sample	5	5
Tear, Rip or Hole in Device Packaging	5	5
Loose or Intermittent Connection	4	4
Device Difficult to Setup or Prepare	4	4
Device Dislodged or Dislocated	4	4
Failure to Unfold or Unwrap	4	4
Break	4	4
Defective Component	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Improper or Incorrect Procedure or Method	3	7
Device Ingredient or Reagent Problem	3	3
Device Markings/Labelling Problem	3	3
Component Missing	3	3
Mechanical Problem	3	3
Fluid/Blood Leak	2	2
Chemical Problem	2	2
Unexpected Therapeutic Results	2	2
Device Appears to Trigger Rejection	2	2
Melted	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	532	624
Skin Inflammation/ Irritation	270	278
Hypersensitivity/Allergic reaction	202	205
Rash	183	185
Itching Sensation	153	157
Skin Tears	140	140
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	132	132
Erythema	118	121
Blister	116	116
Pain	74	77
Hemorrhage/Bleeding	51	53
Skin Infection	50	50
Abrasion	46	46
Local Reaction	42	42
Burning Sensation	41	42
Contact Dermatitis	38	38
Skin Burning Sensation	35	35
Insufficient Information	34	35
Swelling/ Edema	33	33
Unspecified Infection	28	32
Peeling	24	24
Scar Tissue	23	24
Impaired Healing	21	21
Skin Discoloration	21	21
Caustic/Chemical Burns	20	20
Burn(s)	20	20
Urticaria	19	19
Fluid Discharge	19	19
Unspecified Tissue Injury	16	18
Localized Skin Lesion	16	16
Bacterial Infection	15	15
Tissue Breakdown	11	12
Wound Dehiscence	10	10
Purulent Discharge	9	10
Dyspnea	9	9
Laceration(s)	8	11
Discomfort	8	8
Skin Erosion	8	8
Cellulitis	8	8
Inflammation	7	7
Post Operative Wound Infection	7	7
Superficial (First Degree) Burn	7	7
Ulcer	6	6
Necrosis	6	6
Partial thickness (Second Degree) Burn	6	6
Skin Disorders	6	6
Wheal(s)	6	6
Bradycardia	4	4
No Patient Involvement	4	4
Unintended Extubation	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	3M Company - Health Care Business	II	Apr-24-2024
2	3M Company - Health Care Business	II	Apr-03-2024
3	ASO LLC	II	May-02-2023
4	Cardinal Health 200, LLC	II	May-16-2024
5	Family Dollar Stores, Llc.	II	Aug-17-2022
6	Ferndale Laboratories, Inc.	II	Dec-31-2025
7	GOLD STAR DISTRIBUTION INC	II	Jan-27-2026
8	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-29-2024
9	Mckesson Medical-Surgical Inc. Corporate Office	III	Sep-26-2022
10	Medline Industries, LP	II	Dec-11-2025