TPLC - Total Product Life Cycle

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

MDR Year	MDR Reports	MDR Events
2019	484	484
2020	1290	1290
2021	560	560
2022	253	253
2023	193	193
2024	142	146

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1138	1138
Loss of or Failure to Bond	734	734
Material Integrity Problem	153	153
Delivered as Unsterile Product	116	116
Insufficient Information	92	92
Patient-Device Incompatibility	61	61
Device Slipped	54	54
Detachment of Device or Device Component	50	50
Contamination /Decontamination Problem	49	49
Appropriate Term/Code Not Available	43	43
Biocompatibility	33	33
Product Quality Problem	32	32
Migration	30	30
Nonstandard Device	29	29
Defective Device	26	26
Peeled/Delaminated	25	25
Difficult to Remove	25	25
Device Dislodged or Dislocated	24	24
Unintended Movement	20	20
Mechanical Problem	19	19
Packaging Problem	18	18
Patient Device Interaction Problem	18	18
Physical Resistance/Sticking	17	17
Defective Component	17	17
Material Separation	16	16
Material Disintegration	14	14
Failure to Obtain Sample	14	14
Unsealed Device Packaging	13	13
Device Contamination with Chemical or Other Material	12	12
Use of Device Problem	12	12
Material Deformation	11	11
Contamination	11	11
Leak/Splash	10	10
Device Contaminated During Manufacture or Shipping	9	9
Manufacturing, Packaging or Shipping Problem	8	8
Separation Problem	7	7
Device Difficult to Setup or Prepare	6	6
Improper or Incorrect Procedure or Method	5	5
Difficult to Open or Close	5	9
Difficult to Open or Remove Packaging Material	5	5
Problem with Sterilization	4	4
Failure to Unfold or Unwrap	4	4
Tear, Rip or Hole in Device Packaging	4	4
Therapeutic or Diagnostic Output Failure	3	3
Microbial Contamination of Device	3	3
Component Missing	3	3
Device Markings/Labelling Problem	3	3
Device Contamination with Body Fluid	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	613	617
No Known Impact Or Consequence To Patient	602	602
Injury	279	279
No Consequences Or Impact To Patient	230	230
Unspecified Infection	210	210
Rash	186	186
Skin Inflammation/ Irritation	137	137
Itching Sensation	125	125
Erythema	112	112
No Patient Involvement	108	108
Hypersensitivity/Allergic reaction	106	106
Skin Irritation	104	104
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	100	100
Skin Tears	99	99
Pain	89	89
Blister	83	83
No Code Available	79	79
Peeling	67	67
Abrasion	50	50
Burning Sensation	50	50
Skin Infection	39	39
Unspecified Tissue Injury	38	38
Local Reaction	38	38
Hemorrhage/Bleeding	35	35
Swelling	35	35
Bacterial Infection	34	34
Insufficient Information	34	34
Reaction	32	32
Skin Burning Sensation	26	26
Contact Dermatitis	25	25
Skin Discoloration	25	25
Purulent Discharge	23	23
Fluid Discharge	22	22
Impaired Healing	21	21
Burn(s)	21	21
Swelling/ Edema	20	20
Post Operative Wound Infection	20	20
Scar Tissue	18	18
Wound Dehiscence	18	18
Wheal(s)	18	18
Caustic/Chemical Burns	16	16
Failure of Implant	15	15
Tissue Breakdown	13	13
Localized Skin Lesion	12	12
Urticaria	10	10
Dyspnea	8	8
Skin Erosion	7	7
Ulcer	7	7
Inflammation	7	7
Necrosis	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	3M Company - Health Care Business	II	Dec-20-2019
4	ASO LLC	II	May-02-2023
5	Cardinal Health 200, LLC	II	May-16-2024
6	Family Dollar Stores, Llc.	II	Aug-17-2022
7	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-29-2024
8	Mckesson Medical-Surgical Inc. Corporate Office	III	Sep-26-2022