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 HEALTH CARE BUSINESS GROUP
	SUBSTANTIALLY EQUIVALENT	4
ALLEVA MEDICAL DEVICES
	SUBSTANTIALLY EQUIVALENT	1
ALLEVA MEDICAL LTD
	SUBSTANTIALLY EQUIVALENT	1
APPLIED TISSUE TECHNOLOGIES LLC
	SUBSTANTIALLY EQUIVALENT	1
CARDINAL HEALTH
	SUBSTANTIALLY EQUIVALENT	2
CARILEX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
CLEAR CHOICE THERAPEUTICS
	SUBSTANTIALLY EQUIVALENT	1
CLEAR CHOICE THERAPEUTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CORK MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
CORK MEDICAL PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
DEROYAL INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
GENADYNE BIOTECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
GENADYNE BIOTECHNOLOGIES, INC
	SUBSTANTIALLY EQUIVALENT	1
GENADYNE BIOTECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
KCI USA, INC
	SUBSTANTIALLY EQUIVALENT	2
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
PENSAR MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	3
SMITH & NEPHEW MEDICAL LTD
	SUBSTANTIALLY EQUIVALENT	2
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	1060	1060
Collapse	896	1638
Suction Failure	626	626
False Alarm	523	523
Failure to Charge	504	504
Pumping Stopped	452	452
Insufficient Information	222	222
Obstruction of Flow	219	219
Defective Alarm	216	216
Improper or Incorrect Procedure or Method	192	192
Unexpected Shutdown	148	148
Device Alarm System	140	140
Protective Measures Problem	107	107
Defective Device	85	85
Suction Problem	81	81
Leak/Splash	79	79
Failure to Power Up	76	76
Overheating of Device	73	73
Failure to Pump	66	66
Gas/Air Leak	46	46
No Pressure	46	46
Loss of or Failure to Bond	42	42
Device Emits Odor	41	41
Battery Problem	37	37
No Audible Alarm	36	36
Use of Device Problem	30	30
Break	29	29
Pumping Problem	28	28
Defective Component	28	28
Alarm Not Visible	24	24
Crack	24	24
Complete Blockage	22	22
Fluid/Blood Leak	20	20
Pressure Problem	20	20
Decrease in Suction	17	17
Melted	17	17
Noise, Audible	16	16
Infusion or Flow Problem	15	15
No Apparent Adverse Event	14	14
Material Integrity Problem	14	14
Delivered as Unsterile Product	14	14
Fire	13	13
Power Problem	12	12
Smoking	12	12
Therapeutic or Diagnostic Output Failure	12	12
Decrease in Pressure	11	11
Appropriate Term/Code Not Available	10	10
Image Display Error/Artifact	10	10
Failure of Device to Self-Test	10	10
Electrical /Electronic Property Problem	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2299	3041
No Consequences Or Impact To Patient	1264	2006
No Patient Involvement	608	948
No Known Impact Or Consequence To Patient	452	452
Unspecified Infection	416	416
Injury	233	233
Bacterial Infection	132	133
Insufficient Information	121	121
Hemorrhage/Bleeding	110	110
Tissue Breakdown	92	92
Wound Dehiscence	88	88
Fungal Infection	85	85
Foreign Body In Patient	84	84
Necrosis	81	81
Post Operative Wound Infection	66	66
Device Embedded In Tissue or Plaque	65	65
Impaired Healing	49	49
Pain	41	41
No Information	29	29
Zonular Dehiscence	27	27
Failure of Implant	27	27
Abscess	25	25
Skin Disorders	19	19
Blister	19	19
Sepsis	19	19
Hematoma	19	19
Cellulitis	18	18
No Code Available	17	17
Swelling/ Edema	16	16
Skin Inflammation/ Irritation	15	15
Fistula	15	15
Unspecified Tissue Injury	13	13
Fluid Discharge	13	13
Tissue Damage	10	10
Fever	10	10
Purulent Discharge	9	9
Osteomyelitis	9	9
Skin Infection	9	9
Hypersensitivity/Allergic reaction	9	9
Patient Problem/Medical Problem	8	8
Inflammation	8	8
Fall	7	7
Drug Resistant Bacterial Infection	7	7
Discomfort	6	6
Cyst(s)	6	6
Seroma	6	6
Skin Irritation	6	6
Erythema	6	6
Rash	6	7
Localized Skin Lesion	6	6