TPLC - Total Product Life Cycle

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Device	cutaneous tissue adhesive with mesh
Regulation Description	Tissue adhesive with adjunct wound closure device for topical approximation of skin.
Definition	For topical application only to hold closed easily approximated skin edges of wounds such as wounds from surgical incisions, including punctures from minimally invasive surgery, and simple thorough cleansed, trauma-induced lacerations. The device may be used in conjunction with, but not in place of, deep dermal sutures.
Product Code	OMD
Regulation Number	878.4011
Device Class	2

Premarket Reviews
Manufacturer	Decision
ADVANCED MEDICAL SOLUTIONS LIMITED
	SUBSTANTIALLY EQUIVALENT	1
CONNEXICON MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	1
ETHICON, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	997	1011
Device Contaminated During Manufacture or Shipping	24	24
Delivered as Unsterile Product	16	16
Appropriate Term/Code Not Available	13	13
Material Separation	11	11
Patient-Device Incompatibility	9	9
Device Markings/Labelling Problem	8	8
Patient Device Interaction Problem	6	6
Material Integrity Problem	4	4
Coagulation in Device or Device Ingredient	4	4
Lack of Effect	3	3
Insufficient Information	2	2
Use of Device Problem	2	2
Chemical Problem	1	1
Off-Label Use	1	1
Output Problem	1	1
Component Missing	1	1
Product Quality Problem	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Skin Inflammation/ Irritation	444	444
Blister	211	225
Hypersensitivity/Allergic reaction	203	203
Rash	194	208
Erythema	182	182
Itching Sensation	164	164
Wound Dehiscence	135	135
Unspecified Infection	132	132
Local Reaction	94	94
Inflammation	79	79
No Clinical Signs, Symptoms or Conditions	56	56
Impaired Healing	53	53
Necrosis	49	49
Fluid Discharge	37	37
Burning Sensation	33	33
Burn(s)	29	29
Insufficient Information	25	25
Swelling/ Edema	24	24
Skin Discoloration	23	23
Pain	21	21
Hematoma	15	15
Hemorrhage/Bleeding	14	14
Scar Tissue	13	13
Post Operative Wound Infection	13	13
Discomfort	11	11
Seroma	11	11
Abrasion	11	11
Cellulitis	10	10
Urticaria	9	9
Unspecified Tissue Injury	8	8
Purulent Discharge	7	7
Abscess	4	4
Anaphylactoid	3	3
Post Traumatic Wound Infection	3	3
Chills	3	3
Bacterial Infection	3	3
Contact Dermatitis	3	3
Skin Disorders	2	2
Urinary Tract Infection	2	2
Fever	2	2
Emotional Changes	2	2
Skin Erosion	2	2
Fatigue	2	2
Nausea	2	2
Thromboembolism	2	2
Skin Infection	2	2
Partial thickness (Second Degree) Burn	2	2
Anxiety	2	2
Distress	1	1
Pulmonary Embolism	1	1