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	63	69

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	601	606
Loss of or Failure to Bond	238	254
Patient Device Interaction Problem	102	105
Patient-Device Incompatibility	71	75
Biocompatibility	61	64
Contamination /Decontamination Problem	48	48
Use of Device Problem	42	42
Material Integrity Problem	40	40
Delivered as Unsterile Product	38	39
Insufficient Information	21	21
Difficult to Open or Close	18	94
Nonstandard Device	18	18
Packaging Problem	18	18
Difficult to Remove	15	15
Physical Resistance/Sticking	14	14
Material Separation	14	14
Unsealed Device Packaging	13	14
Appropriate Term/Code Not Available	12	12
Output Problem	12	15
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
Separation Problem	7	7
Detachment of Device or Device Component	7	7
Defective Device	7	7
Leak/Splash	6	6
Device Contamination with Chemical or Other Material	6	6
Tear, Rip or Hole in Device Packaging	5	5
Failure to Obtain Sample	5	5
Moisture Damage	5	5
Loose or Intermittent Connection	4	4
Device Dislodged or Dislocated	4	4
Failure to Unfold or Unwrap	4	4
Device Difficult to Setup or Prepare	4	4
Break	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Defective Component	3	3
Component Missing	3	3
Device Markings/Labelling Problem	3	3
Difficult to Open or Remove Packaging Material	3	3
Mechanical Problem	3	3
Improper or Incorrect Procedure or Method	3	7
Microbial Contamination of Device	2	2
Therapeutic or Diagnostic Output Failure	2	2
Problem with Sterilization	2	2
Moisture or Humidity Problem	2	2
Material Deformation	2	2
Inadequacy of Device Shape and/or Size	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	514	606
Skin Inflammation/ Irritation	259	267
Hypersensitivity/Allergic reaction	193	196
Rash	178	180
Itching Sensation	147	151
Skin Tears	140	140
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	130	130
Erythema	116	119
Blister	115	115
Pain	71	74
Hemorrhage/Bleeding	51	53
Skin Infection	49	49
Abrasion	45	45
Burning Sensation	41	42
Local Reaction	41	41
Contact Dermatitis	37	37
Skin Burning Sensation	35	35
Insufficient Information	34	35
Swelling/ Edema	31	31
Unspecified Infection	27	31
Peeling	24	24
Scar Tissue	23	24
Skin Discoloration	21	21
Impaired Healing	20	20
Burn(s)	20	20
Caustic/Chemical Burns	19	19
Urticaria	18	18
Fluid Discharge	18	18
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
Skin Erosion	8	8
Discomfort	8	8
Cellulitis	8	8
Laceration(s)	8	11
Dyspnea	8	8
Post Operative Wound Infection	7	7
Inflammation	7	7
Superficial (First Degree) Burn	7	7
Skin Disorders	6	6
Necrosis	6	6
Ulcer	6	6
Partial thickness (Second Degree) Burn	6	6
Wheal(s)	6	6
Bradycardia	4	4
Unintended Extubation	4	4
No Patient Involvement	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