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
2020	1290	1293
2021	562	567
2022	253	260
2023	192	195
2024	224	235
2025	273	348

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1029	1031
Loss of or Failure to Bond	651	667
Material Integrity Problem	152	152
Insufficient Information	83	83
Patient Device Interaction Problem	80	83
Patient-Device Incompatibility	69	75
Biocompatibility	62	62
Device Slipped	54	54
Detachment of Device or Device Component	51	52
Contamination /Decontamination Problem	49	49
Delivered as Unsterile Product	41	41
Appropriate Term/Code Not Available	34	34
Product Quality Problem	32	32
Migration	30	30
Nonstandard Device	29	29
Use of Device Problem	26	26
Device Dislodged or Dislocated	24	24
Unintended Movement	20	20
Defective Device	20	20
Packaging Problem	18	18
Physical Resistance/Sticking	17	17
Difficult to Remove	17	17
Difficult to Open or Close	16	87
Material Separation	16	16
Peeled/Delaminated	15	15
Material Disintegration	14	14
Unsealed Device Packaging	14	14
Defective Component	13	13
Contamination	11	11
Material Deformation	10	10
Leak/Splash	10	10
Device Contaminated During Manufacture or Shipping	9	9
Manufacturing, Packaging or Shipping Problem	8	8
Device Contamination with Chemical or Other Material	8	8
Failure to Obtain Sample	7	7
Separation Problem	7	7
Adhesive Too Strong	7	7
Moisture Damage	6	6
Device Difficult to Setup or Prepare	6	6
Improper or Incorrect Procedure or Method	5	9
Difficult to Open or Remove Packaging Material	5	5
Tear, Rip or Hole in Device Packaging	4	4
Failure to Unfold or Unwrap	4	4
Mechanical Problem	4	4
Problem with Sterilization	4	4
Component Missing	3	3
Device Markings/Labelling Problem	3	3
Microbial Contamination of Device	3	3
Break	3	3
Missing Information	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	652	739
No Known Impact Or Consequence To Patient	466	466
Injury	257	257
Skin Inflammation/ Irritation	227	232
No Consequences Or Impact To Patient	203	203
Rash	196	200
Unspecified Infection	189	193
Hypersensitivity/Allergic reaction	177	180
Itching Sensation	152	158
Skin Tears	136	136
Erythema	124	129
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	123	123
Blister	119	119
Pain	91	92
Hemorrhage/Bleeding	51	53
Burning Sensation	50	51
Skin Infection	49	49
Abrasion	48	48
Unspecified Tissue Injury	46	48
Local Reaction	45	45
Insufficient Information	43	44
No Code Available	43	43
Skin Irritation	43	44
Peeling	41	41
Bacterial Infection	35	35
Contact Dermatitis	34	34
Skin Discoloration	33	33
Skin Burning Sensation	33	33
Swelling/ Edema	30	30
Fluid Discharge	28	28
No Patient Involvement	26	26
Purulent Discharge	25	26
Scar Tissue	22	23
Impaired Healing	22	22
Post Operative Wound Infection	21	21
Caustic/Chemical Burns	20	20
Burn(s)	18	18
Failure of Implant	15	15
Localized Skin Lesion	15	15
Urticaria	14	14
Tissue Breakdown	14	15
Wound Dehiscence	14	14
Reaction	14	14
Wheal(s)	13	13
Cellulitis	9	9
Discomfort	8	8
Skin Erosion	8	8
Ulcer	8	8
Dyspnea	8	8
Swelling	7	7

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	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-29-2024
7	Mckesson Medical-Surgical Inc. Corporate Office	III	Sep-26-2022