TPLC - Total Product Life Cycle

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Device	negative pressure wound therapy powered suction pump
Regulation Description	Powered suction pump.
Definition	For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
Product Code	OMP
Regulation Number	878.4780
Device Class	2

Premarket Reviews
Manufacturer	Decision
3M
	SUBSTANTIALLY EQUIVALENT	2
3M HEALTHCARE BUSINESS GROUP
	SUBSTANTIALLY EQUIVALENT	4
ALLEVA MEDICAL DEVICES
	SUBSTANTIALLY EQUIVALENT	2
ALLEVA MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	1
APPLIED TISSUE TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
BECHTEL MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
CARDINALHEALTH
	SUBSTANTIALLY EQUIVALENT	1
CARILEX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
CG BIO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CLEAR CHOICE THERAPEUTICS
	SUBSTANTIALLY EQUIVALENT	1
CLEAR CHOICE THERAPEUTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CONVATEC LIMITED, GDC BUILDING
	SUBSTANTIALLY EQUIVALENT	1
CORK MEDICAL
	SUBSTANTIALLY EQUIVALENT	4
CORK MEDICAL PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
DEROYAL INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
GENADYNE BIOTECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	5
KCI USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
KCI, A PART OF 3M HEALTH CARE BUSINESS GROUP
	SUBSTANTIALLY EQUIVALENT	1
LIGHTSTONE MEDICAL PRODUCTS (NINGBO) CO, LTD.
	SUBSTANTIALLY EQUIVALENT	1
MED WAY, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDELA AG
	SUBSTANTIALLY EQUIVALENT	2
MOLNLYCKE HEALTH CARE US, LLC
	SUBSTANTIALLY EQUIVALENT	1
NEXA MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	2
SMITH & NEPHEW MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	4
SMITH AND NEPHEW MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SMITH NEPHEW MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG LONGTERM MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	513	513
Suction Failure	392	392
Pumping Stopped	209	209
Improper or Incorrect Procedure or Method	200	200
False Alarm	145	145
Defective Alarm	111	111
Obstruction of Flow	104	104
Failure to Charge	50	50
Protective Measures Problem	47	47
Suction Problem	46	46
Collapse	43	43
Overheating of Device	41	41
Loss of or Failure to Bond	34	34
Device Emits Odor	30	30
Insufficient Device Problem Information	30	30
Gas/Air Leak	26	26
Leak/Splash	24	24
Crack	22	22
No Audible Alarm	22	22
Failure to Power Up	19	19
Use of Device Problem	18	18
Delivered as Unsterile Product	18	18
Unexpected Shutdown	17	17
Defective Component	17	17
Defective Device	16	16
Fluid/Blood Leak	16	16
Device Alarm System	15	15
Break	14	14
Fire	14	14
Alarm Not Visible	12	12
Smoking	11	11
Failure of Device to Self-Test	11	11
Noise, Audible	11	11
Battery Problem	9	9
Arcing	9	9
Decrease in Suction	9	9
Thermal Decomposition of Device	8	8
Infusion or Flow Problem	8	8
Material Integrity Problem	8	8
Material Separation	8	8
Patient Device Interaction Problem	7	7
Power Problem	7	7
Off-Label Use	6	6
Decrease in Pressure	6	6
Complete Loss of Power	6	6
Biocompatibility	6	6
Material Fragmentation	5	5
Difficult to Remove	5	5
Melted	5	5
Device Contamination with Chemical or Other Material	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1233	1236
Bacterial Infection	116	116
Hemorrhage/Blood Loss/Bleeding	114	114
Insufficient Information	92	93
Unspecified Infection	84	84
Fungal Infection	80	80
Device Embedded In Tissue or Plaque	77	77
Foreign Body In Patient	66	66
Tissue Breakdown	64	64
Impaired Healing	53	53
Necrosis	52	52
Wound Dehiscence	47	47
Post Operative Wound Infection	41	41
Pain	32	32
Blister	23	23
Failure of Implant	21	21
Skin Disorders	20	20
Sepsis	20	20
Cellulitis	18	18
Hematoma	16	16
Abscess	15	15
Skin Inflammation/ Irritation	15	15
Wound Infection	12	12
Swelling/ Edema	12	12
Fistula	11	11
Hypersensitivity/Allergic reaction	11	11
Fluid Discharge	11	11
Osteomyelitis	9	9
Purulent Discharge	9	9
Drug Resistant Bacterial Infection	8	8
Seroma	8	8
Skin Infection	8	8
Fall	7	7
Laceration(s)	6	6
Fever	6	6
Cyst(s)	6	6
Discomfort	6	6
Localized Skin Lesion	6	6
Rash	6	6
Foreign Body Reaction	5	5
Exsanguination	5	5
Skin Maceration	5	5
Ulcer	4	4
Itching Sensation	4	4
Unspecified Tissue Injury	4	4
Rupture	4	4
Ischemia	3	3
Local Reaction	3	3
Inflammation	3	3
Erythema	3	3