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
CARDINALHEALTH
	SUBSTANTIALLY EQUIVALENT	1
CARILEX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
CLEAR CHOICE THERAPEUTICS
	SUBSTANTIALLY EQUIVALENT	1
CLEAR CHOICE THERAPEUTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CORK MEDICAL
	SUBSTANTIALLY EQUIVALENT	3
CORK MEDICAL PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
DEROYAL INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
GENADYNE BIOTECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	4
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	3
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	507	507
Suction Failure	406	408
Pumping Stopped	214	214
Improper or Incorrect Procedure or Method	196	196
False Alarm	146	146
Defective Alarm	113	113
Obstruction of Flow	107	107
Protective Measures Problem	51	51
Suction Problem	51	51
Failure to Charge	50	50
Overheating of Device	49	49
Collapse	43	43
Loss of or Failure to Bond	34	34
Device Emits Odor	30	30
Insufficient Information	29	29
Leak/Splash	27	28
No Audible Alarm	23	23
Device Alarm System	23	23
Failure to Power Up	22	22
Crack	22	22
Defective Device	20	20
Unexpected Shutdown	18	18
Defective Component	18	19
Gas/Air Leak	18	18
Delivered as Unsterile Product	16	16
Fire	16	16
Use of Device Problem	16	16
Fluid/Blood Leak	16	16
Break	14	14
Melted	13	13
Battery Problem	12	12
Alarm Not Visible	12	12
Smoking	12	12
Noise, Audible	11	11
Failure of Device to Self-Test	11	11
Decrease in Suction	10	10
Thermal Decomposition of Device	9	9
Power Problem	8	8
Infusion or Flow Problem	8	8
Material Integrity Problem	8	8
Patient Device Interaction Problem	7	7
Decrease in Pressure	7	7
Arcing	7	7
Device Contamination with Chemical or Other Material	6	6
Therapeutic or Diagnostic Output Failure	6	6
Complete Loss of Power	6	6
Output Problem	6	6
Off-Label Use	6	6
Sparking	5	5
Patient-Device Incompatibility	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1214	1217
Bacterial Infection	113	113
Hemorrhage/Bleeding	111	111
Insufficient Information	91	92
Unspecified Infection	83	83
Fungal Infection	78	78
Device Embedded In Tissue or Plaque	74	74
Foreign Body In Patient	65	65
Tissue Breakdown	64	64
Impaired Healing	51	51
Necrosis	50	50
Wound Dehiscence	47	47
Post Operative Wound Infection	41	41
Pain	32	32
Blister	21	21
Failure of Implant	21	21
Skin Disorders	20	20
Sepsis	20	20
Cellulitis	18	18
Hematoma	16	16
Abscess	15	15
Skin Inflammation/ Irritation	14	14
Swelling/ Edema	12	12
Fistula	11	11
Hypersensitivity/Allergic reaction	11	11
Fluid Discharge	11	11
Post Traumatic Wound Infection	10	10
Osteomyelitis	9	9
Drug Resistant Bacterial Infection	8	8
Purulent Discharge	8	8
Skin Infection	8	8
Seroma	7	7
Fall	7	7
Discomfort	6	6
Laceration(s)	6	6
Fever	6	6
Cyst(s)	6	6
Localized Skin Lesion	6	6
Rash	5	5
Exsanguination	5	5
Foreign Body Reaction	5	5
Unspecified Tissue Injury	4	4
Ulcer	4	4
Rupture	4	4
Itching Sensation	3	3
Local Reaction	3	3
Ischemia	3	3
Inflammation	3	3
Skin Tears	3	3
Skin Erosion	3	3