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	588	595
Patient Device Interaction Problem	128	128
Device Contaminated During Manufacture or Shipping	66	66
Patient-Device Incompatibility	35	39
Delivered as Unsterile Product	11	11
Material Integrity Problem	8	8
Break	7	7
Use of Device Problem	7	7
Material Separation	5	5
Appropriate Term/Code Not Available	5	5
Improper or Incorrect Procedure or Method	5	5
Output Problem	4	4
Activation Problem	4	4
Lack of Effect	4	4
Packaging Problem	3	3
Unexpected Therapeutic Results	3	3
Insufficient Information	2	2
Defective Device	2	2
Coagulation in Device or Device Ingredient	2	2
Peeled/Delaminated	1	1
Device Markings/Labelling Problem	1	1
Material Puncture/Hole	1	1
Defective Component	1	1
Material Discolored	1	1
Sharp Edges	1	1
Unintended Compatibility	1	1
Material Deformation	1	2
Material Protrusion/Extrusion	1	1
Human-Device Interface Problem	1	1
Difficult to Open or Close	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Skin Inflammation/ Irritation	281	282
No Clinical Signs, Symptoms or Conditions	214	215
Hypersensitivity/Allergic reaction	134	136
Erythema	134	136
Rash	133	136
Itching Sensation	103	108
Wound Dehiscence	77	78
Unspecified Infection	76	81
Blister	70	71
Swelling/ Edema	64	64
Local Reaction	44	48
Inflammation	38	39
Pain	37	37
Impaired Healing	31	31
Fluid Discharge	28	28
Insufficient Information	25	25
Contact Dermatitis	14	14
Urticaria	13	13
Burning Sensation	13	14
Hemorrhage/Bleeding	12	12
Fever	12	12
Post Operative Wound Infection	12	12
Skin Discoloration	11	11
Cellulitis	11	11
Scar Tissue	10	10
Necrosis	10	10
Purulent Discharge	10	10
Laceration(s)	7	7
Hematoma	7	8
Seroma	6	6
Burn(s)	5	6
Abscess	5	5
Discomfort	4	4
Nausea	4	4
Caustic/Chemical Burns	4	4
Ischemia	3	3
Skin Burning Sensation	3	3
Unspecified Tissue Injury	3	3
Swollen Lymph Nodes/Glands	2	2
Pocket Erosion	2	2
Low Blood Pressure/ Hypotension	2	2
Corneal Ulcer	2	2
Asthma	2	2
Abrasion	2	2
Chills	2	2
Needle Stick/Puncture	2	2
Hernia	2	2
Dizziness	2	2
Ecchymosis	2	2
Eye Injury	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