TPLC - Total Product Life Cycle

show TPLC since

Device	system, suction, lipoplasty
Regulation Description	Suction lipoplasty system.
Definition	See Federal Register Notice at 86 FR 50887 “Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Products at the Point of Care to Produce a Therapeutic Article” (FRN) (FDA-2021-N-0881).
Product Code	MUU
Regulation Number	878.5040
Device Class	2

Premarket Reviews
Manufacturer	Decision
BSL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
LIFECELL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MILLENNIUM MEDICAL TECHNOLOGIES INC (DBA CELLMYX)
	SUBSTANTIALLY EQUIVALENT	1
PUREGRAFT LLC
	SUBSTANTIALLY EQUIVALENT	1
SYNTR HEALTH TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	32	32
Break	26	26
Leak/Splash	14	14
Insufficient Information	9	9
Failure to Power Up	9	9
Mechanical Problem	6	6
Suction Failure	6	6
Fluid/Blood Leak	4	4
Fracture	4	4
Activation Failure	4	4
Output Problem	4	4
Energy Output Problem	4	4
Patient-Device Incompatibility	3	3
Material Twisted/Bent	3	3
Improper or Incorrect Procedure or Method	2	2
Power Problem	2	2
Device Emits Odor	2	2
Infusion or Flow Problem	2	2
Use of Device Problem	2	2
Pumping Stopped	2	2
Wireless Communication Problem	2	2
Failure to Deliver Energy	2	2
Moisture Damage	1	1
Therapeutic or Diagnostic Output Failure	1	1
Failure to Deliver	1	1
Degraded	1	1
Defective Device	1	1
Defective Component	1	1
Component Missing	1	1
Obstruction of Flow	1	1
Improper Flow or Infusion	1	1
Filtration Problem	1	1
Electrical Power Problem	1	1
Date/Time-Related Software Problem	1	1
Crack	1	1
Product Quality Problem	1	1
Detachment of Device or Device Component	1	1
Device Contamination with Body Fluid	1	1
Unexpected Shutdown	1	1
Activation, Positioning or Separation Problem	1	1
Appropriate Term/Code Not Available	1	1
Suction Problem	1	1
Electrical /Electronic Property Problem	1	1
Fitting Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	78	78
Burn(s)	10	10
Seroma	7	7
No Patient Involvement	7	7
Pain	7	7
Partial thickness (Second Degree) Burn	7	7
No Consequences Or Impact To Patient	7	7
No Code Available	6	6
Necrosis	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Insufficient Information	5	5
Full thickness (Third Degree) Burn	5	5
Swelling/ Edema	4	4
Bacterial Infection	4	4
Foreign Body In Patient	3	3
Scar Tissue	3	3
Deformity/ Disfigurement	3	3
Impaired Healing	2	2
Skin Inflammation/ Irritation	2	2
Blister	2	2
Breast Mass	1	1
Intraoperative Pain	1	1
Cyst(s)	1	1
Scarring	1	1
Post Operative Wound Infection	1	1
No Known Impact Or Consequence To Patient	1	1
Loss of Range of Motion	1	1
Swelling	1	1
Laceration(s)	1	1
Abscess	1	1
Unspecified Tissue Injury	1	1
Subcutaneous Nodule	1	1
Bruise/Contusion	1	1
Ambulation Difficulties	1	1