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	593	600
Patient Device Interaction Problem	130	130
Device Contaminated During Manufacture or Shipping	68	68
Patient-Device Incompatibility	36	40
Delivered as Unsterile Product	11	11
Material Integrity Problem	8	8
Use of Device Problem	8	8
Break	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
Mechanical Problem	2	2
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	284	285
No Clinical Signs, Symptoms or Conditions	216	217
Erythema	136	138
Hypersensitivity/Allergic reaction	135	137
Rash	134	137
Itching Sensation	104	109
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
Hemorrhage/Bleeding	14	14
Urticaria	13	13
Burning Sensation	13	14
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
Abscess	7	7
Laceration(s)	7	7
Hematoma	7	8
Seroma	6	6
Burn(s)	5	6
Discomfort	4	4
Nausea	4	4
Caustic/Chemical Burns	4	4
Ischemia	3	3
Eye Injury	3	3
Skin Burning Sensation	3	3
Unspecified Tissue Injury	3	3
Pocket Erosion	2	2
Low Blood Pressure/ Hypotension	2	2
Swollen Lymph Nodes/Glands	2	2
Corneal Ulcer	2	2
Asthma	2	2
Abrasion	2	2
Chills	2	2
Needle Stick/Puncture	2	2
Hernia	2	2
Unspecified Eye / Vision Problem	2	2
Ecchymosis	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