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	62	65

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	967	967
Loss of or Failure to Bond	639	648
Material Integrity Problem	151	151
Insufficient Information	79	79
Device Slipped	54	54
Patient-Device Incompatibility	50	50
Detachment of Device or Device Component	49	49
Contamination /Decontamination Problem	49	49
Biocompatibility	41	41
Delivered as Unsterile Product	37	37
Appropriate Term/Code Not Available	33	33
Product Quality Problem	32	32
Migration	30	30
Nonstandard Device	29	29
Device Dislodged or Dislocated	24	24
Patient Device Interaction Problem	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
Difficult to Remove	14	14
Unsealed Device Packaging	13	13
Defective Component	13	13
Contamination	11	11
Leak/Splash	10	10
Material Deformation	10	10
Use of Device Problem	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
Difficult to Open or Close	7	12
Failure to Obtain Sample	7	7
Separation Problem	7	7
Device Difficult to Setup or Prepare	6	6
Improper or Incorrect Procedure or Method	5	5
Moisture Damage	5	5
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
Problem with Sterilization	4	4
Missing Information	3	3
Break	3	3
Mechanical Problem	3	3
Component Missing	3	3
Microbial Contamination of Device	3	3
Therapeutic or Diagnostic Output Failure	3	3
Device Markings/Labelling Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	623	637
No Known Impact Or Consequence To Patient	466	466
Injury	257	257
No Consequences Or Impact To Patient	203	203
Unspecified Infection	189	189
Rash	179	179
Skin Inflammation/ Irritation	167	167
Hypersensitivity/Allergic reaction	136	136
Itching Sensation	129	129
Skin Tears	113	113
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	109	109
Erythema	104	104
Blister	102	102
Pain	81	81
Local Reaction	44	44
No Code Available	43	43
Hemorrhage/Bleeding	42	42
Skin Irritation	42	42
Abrasion	41	41
Burning Sensation	41	41
Insufficient Information	40	40
Peeling	40	40
Unspecified Tissue Injury	40	40
Skin Infection	40	40
Bacterial Infection	34	34
Skin Burning Sensation	32	32
Contact Dermatitis	29	29
Skin Discoloration	29	29
No Patient Involvement	26	26
Fluid Discharge	24	24
Purulent Discharge	24	24
Swelling/ Edema	23	23
Impaired Healing	21	21
Scar Tissue	20	20
Post Operative Wound Infection	20	20
Caustic/Chemical Burns	19	19
Burn(s)	17	17
Failure of Implant	15	15
Reaction	14	14
Localized Skin Lesion	13	13
Wheal(s)	13	13
Tissue Breakdown	13	13
Wound Dehiscence	12	12
Urticaria	10	10
Ulcer	8	8
Skin Erosion	8	8
Dyspnea	8	8
Inflammation	7	7
Swelling	7	7
Discomfort	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