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	50	53

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1108	1108
Loss of or Failure to Bond	728	728
Material Integrity Problem	152	152
Delivered as Unsterile Product	111	111
Insufficient Information	89	89
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
Product Quality Problem	31	31
Migration	30	30
Nonstandard Device	29	29
Defective Device	26	26
Biocompatibility	25	25
Difficult to Remove	25	25
Peeled/Delaminated	25	25
Device Dislodged or Dislocated	24	24
Unintended Movement	20	20
Mechanical Problem	19	19
Packaging Problem	18	18
Patient Device Interaction Problem	17	17
Defective Component	17	17
Physical Resistance/Sticking	17	17
Material Separation	16	16
Material Disintegration	14	14
Failure to Obtain Sample	14	14
Device Contamination with Chemical or Other Material	12	12
Unsealed Device Packaging	12	12
Use of Device Problem	12	12
Contamination	11	11
Material Deformation	11	11
Device Contaminated During Manufacture or Shipping	9	9
Leak/Splash	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 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
Break	3	3
Device Contamination with Body Fluid	3	3
Microbial Contamination of Device	3	3
Device Markings/Labelling Problem	3	3
Difficult to Open or Close	3	6
Therapeutic or Diagnostic Output Failure	3	3
Missing Information	3	3
Premature Separation	2	2
Device Fell	2	2
Moisture or Humidity Problem	2	2
Positioning Problem	2	2
Infusion or Flow Problem	2	2
Chemical Problem	2	2
Component Missing	2	2
Disconnection	2	2
Loose or Intermittent Connection	2	2
Labelling, Instructions for Use or Training Problem	2	2
Melted	2	2
Device Appears to Trigger Rejection	2	2
Material Too Rigid or Stiff	1	1
Off-Label Use	1	1
Pumping Stopped	1	1
Material Puncture/Hole	1	1
Stretched	1	1
Unexpected Therapeutic Results	1	1
Inadequate or Insufficient Training	1	1
Device Damaged Prior to Use	1	1
Inadequacy of Device Shape and/or Size	1	1
Migration or Expulsion of Device	1	1
Moisture Damage	1	1
Fluid/Blood Leak	1	1
Difficult to Fold, Unfold or Collapse	1	1
Obstruction of Flow	1	1
Structural Problem	1	1
Device Ingredient or Reagent Problem	1	1
Material Protrusion/Extrusion	1	1
Inadequate Instructions for Non-Healthcare Professional	1	1
Output Problem	1	1
Material Split, Cut or Torn	1	1
Adhesive Too Strong	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	602	602
No Clinical Signs, Symptoms or Conditions	594	597
Injury	279	279
No Consequences Or Impact To Patient	230	230
Unspecified Infection	210	210
Rash	179	179
Skin Inflammation/ Irritation	120	120
Itching Sensation	116	116
No Patient Involvement	108	108
Erythema	106	106
Skin Irritation	104	104
Hypersensitivity/Allergic reaction	95	95
Skin Tears	92	92
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	91	91
Pain	83	83
No Code Available	79	79
Blister	76	76
Peeling	65	65
Burning Sensation	48	48
Abrasion	46	46
Skin Infection	38	38
Unspecified Tissue Injury	37	37
Local Reaction	36	36
Swelling	35	35
Bacterial Infection	33	33
Reaction	32	32
Hemorrhage/Bleeding	27	27
Insufficient Information	26	26
Skin Burning Sensation	25	25
Skin Discoloration	24	24
Purulent Discharge	22	22
Fluid Discharge	22	22
Contact Dermatitis	21	21
Impaired Healing	21	21
Post Operative Wound Infection	20	20
Burn(s)	19	19
Wound Dehiscence	18	18
Wheal(s)	18	18
Scar Tissue	18	18
Swelling/ Edema	18	18
Caustic/Chemical Burns	15	15
Failure of Implant	15	15
Tissue Breakdown	13	13
Localized Skin Lesion	12	12
Urticaria	10	10
Dyspnea	8	8
Ulcer	7	7
Necrosis	7	7
Skin Erosion	6	6
Scarring	6	6
Inflammation	6	6
Irritation	6	6
Blood Loss	6	6
Extubate	6	6
No Information	6	6
Skin Inflammation	5	5
Skin Disorders	5	5
Bruise/Contusion	5	5
Cellulitis	4	4
Abscess	4	4
Anaphylactic Shock	4	4
Discharge	4	4
Foreign Body In Patient	4	4
Partial thickness (Second Degree) Burn	4	4
Discomfort	4	4
Low Oxygen Saturation	4	4
Superficial (First Degree) Burn	4	4
Burn, Thermal	3	3
Needle Stick/Puncture	3	3
Hypovolemia	3	3
Loss of consciousness	3	3
Sepsis	3	3
Ischemia	3	3
Hyperglycemia	3	3
Edema	2	2
Bradycardia	2	2
Aspiration/Inhalation	2	2
Pleural Effusion	2	2
Vomiting	2	2
Sleep Dysfunction	2	2
Ambulation Difficulties	2	2
Unspecified Respiratory Problem	2	2
Unspecified Eye / Vision Problem	2	2
Unspecified Gastrointestinal Problem	1	1
Angioedema	1	1
Device Embedded In Tissue or Plaque	1	1
Patient Problem/Medical Problem	1	1
Presyncope	1	1
Unspecified Blood or Lymphatic problem	1	1
Embolism/Embolus	1	1
Thrombosis/Thrombus	1	1
Unspecified Vascular Problem	1	1
Chemical Exposure	1	1
Diaphoresis	1	1
Easy Bruising	1	1
Alteration in Body Temperature	1	1
Tachycardia	1	1
Thrombosis	1	1
Tissue Damage	1	1
Laceration(s)	1	1

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	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