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	1290
2021	560	560
2022	253	253
2023	192	192
2024	224	235
2025	145	159

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	996	996
Loss of or Failure to Bond	642	651
Material Integrity Problem	151	151
Insufficient Information	80	80
Patient-Device Incompatibility	57	57
Device Slipped	54	54
Contamination /Decontamination Problem	49	49
Detachment of Device or Device Component	49	49
Biocompatibility	47	47
Patient Device Interaction Problem	47	47
Delivered as Unsterile Product	39	39
Appropriate Term/Code Not Available	34	34
Product Quality Problem	32	32
Migration	30	30
Nonstandard Device	29	29
Device Dislodged or Dislocated	24	24
Unintended Movement	20	20
Defective Device	20	20
Packaging Problem	18	18
Physical Resistance/Sticking	17	17
Material Separation	16	16
Peeled/Delaminated	15	15
Material Disintegration	14	14
Unsealed Device Packaging	14	14
Difficult to Remove	14	14
Defective Component	13	13
Use of Device Problem	13	13
Contamination	11	11
Leak/Splash	10	10
Material Deformation	10	10
Difficult to Open or Close	9	25
Device Contaminated During Manufacture or Shipping	9	9
Device Contamination with Chemical or Other Material	8	8
Manufacturing, Packaging or Shipping Problem	8	8
Separation Problem	7	7
Failure to Obtain Sample	7	7
Moisture Damage	6	6
Device Difficult to Setup or Prepare	6	6
Difficult to Open or Remove Packaging Material	5	5
Improper or Incorrect Procedure or Method	5	5
Tear, Rip or Hole in Device Packaging	4	4
Failure to Unfold or Unwrap	4	4
Adhesive Too Strong	4	4
Problem with Sterilization	4	4
Therapeutic or Diagnostic Output Failure	3	3
Break	3	3
Microbial Contamination of Device	3	3
Mechanical Problem	3	3
Component Missing	3	3
Missing Information	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	631	656
No Known Impact Or Consequence To Patient	466	466
Injury	257	257
No Consequences Or Impact To Patient	203	203
Skin Inflammation/ Irritation	192	192
Unspecified Infection	189	189
Rash	183	183
Hypersensitivity/Allergic reaction	155	155
Itching Sensation	136	136
Skin Tears	124	124
Erythema	115	115
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	114	114
Blister	104	104
Pain	84	84
Hemorrhage/Bleeding	48	48
Burning Sensation	45	45
Skin Infection	45	45
Local Reaction	44	44
Insufficient Information	43	43
No Code Available	43	43
Abrasion	43	43
Unspecified Tissue Injury	43	43
Skin Irritation	42	42
Peeling	40	40
Bacterial Infection	35	35
Skin Burning Sensation	32	32
Skin Discoloration	32	32
Contact Dermatitis	30	30
Swelling/ Edema	28	28
Fluid Discharge	27	27
No Patient Involvement	26	26
Purulent Discharge	24	24
Post Operative Wound Infection	21	21
Impaired Healing	21	21
Scar Tissue	20	20
Caustic/Chemical Burns	19	19
Burn(s)	17	17
Failure of Implant	15	15
Reaction	14	14
Wound Dehiscence	14	14
Wheal(s)	13	13
Localized Skin Lesion	13	13
Tissue Breakdown	13	13
Urticaria	12	12
Dyspnea	8	8
Ulcer	8	8
Discomfort	8	8
Skin Erosion	8	8
Inflammation	7	7
Cellulitis	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