TPLC - Total Product Life Cycle

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Device	tissue adhesive for the topical approximation of skin
Regulation Description	Tissue adhesive.
Definition	Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).
Product Code	MPN
Regulation Number	878.4010
Device Class	2

Premarket Reviews
Manufacturer	Decision
CHEMENCE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
CONNEXICON MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	1
M/S. MERIL ENDO SURGERY PRIVATE LIMITED.
	SUBSTANTIALLY EQUIVALENT	1
OKAPI MEDICAL, LLC DBA RESIVANT MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
OPTMED, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	641	648
Patient Device Interaction Problem	148	148
Device Contaminated During Manufacture or Shipping	79	79
Patient-Device Incompatibility	17	17
Insufficient Device Problem Information	14	14
Delivered as Unsterile Product	12	12
Material Integrity Problem	8	8
Improper or Incorrect Procedure or Method	8	8
Break	6	6
Use of Device Problem	6	6
Material Separation	6	6
Appropriate Device Problem Term/Code Not Available	5	5
Activation Problem	4	4
Lack of Effect	4	4
Packaging Problem	3	3
Mechanical Problem	2	2
Coagulation in Device or Device Ingredient	2	2
Device Markings/Labelling Problem	1	1
Defective Component	1	1
Defective Device	1	1
Material Fragmentation	1	1
Material Discolored	1	1
Infusion or Flow Problem	1	1
Unintended Compatibility	1	1
Human-Device Interface Problem	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Skin Inflammation/ Irritation	309	310
No Clinical Signs, Symptoms or Conditions	240	241
Rash	162	165
Erythema	152	154
Hypersensitivity/Allergic reaction	150	152
Itching Sensation	127	132
Wound Dehiscence	98	99
Blister	85	86
Unspecified Infection	84	89
Swelling/ Edema	64	64
Local Reaction	44	48
Inflammation	41	42
Pain	40	40
Fluid Discharge	37	37
Impaired Healing	33	33
Insufficient Information	33	33
Burning Sensation	21	22
Post Operative Wound Infection	17	17
Hemorrhage/Blood Loss/Bleeding	16	16
Contact Dermatitis	15	15
Skin Discoloration	13	13
Urticaria	13	13
Scar Tissue	12	12
Fever	12	12
Necrosis	11	11
Cellulitis	11	11
Purulent Discharge	10	10
Skin Infection	9	9
Seroma	9	9
Distress	9	9
Hematoma	8	9
Unspecified Tissue Injury	8	8
Abscess	7	7
Laceration(s)	7	7
Eye Injury	5	5
Burn(s)	5	6
Caustic/Chemical Burns	4	4
Nausea	4	4
Skin Burning Sensation	4	4
Discomfort	4	4
Ischemia	3	3
Anxiety	2	2
Calcium Deposits/Calcification	2	2
Low Blood Pressure/ Hypotension	2	2
Pocket Erosion	2	2
Swollen Lymph Nodes/Glands	2	2
Ecchymosis	2	2
Unspecified Eye / Vision Problem	2	2
Hernia	2	2
Foreign Body In Patient	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Ethicon, Inc.	II	Feb-04-2021
2	Mckesson Medical-Surgical Inc. Corporate Office	III	Sep-26-2022