TPLC - Total Product Life Cycle

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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
MILLENNIUM MEDICAL TECHNOLOGIES INC (DBA CELLMYX)
	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	22	23
Leak/Splash	18	18
Break	17	17
Failure to Power Up	10	10
Mechanical Problem	5	5
Insufficient Information	4	4
Activation Failure	4	4
Suction Failure	4	4
Energy Output Problem	4	4
Output Problem	3	3
Failure to Deliver Energy	2	2
Material Twisted/Bent	2	2
Wireless Communication Problem	2	2
Use of Device Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Component Missing	2	2
Patient-Device Incompatibility	2	3
Infusion or Flow Problem	2	2
Device Emits Odor	2	2
Pumping Stopped	2	2
Crack	1	1
Degraded	1	1
Therapeutic or Diagnostic Output Failure	1	1
Unexpected Shutdown	1	1
Suction Problem	1	1
Fitting Problem	1	1
Defective Component	1	1
Device Contamination with Body Fluid	1	1
Failure to Deliver	1	1
Obstruction of Flow	1	1
Date/Time-Related Software Problem	1	1
Defective Device	1	1
Activation, Positioning or Separation Problem	1	1
Detachment of Device or Device Component	1	1
Filtration Problem	1	1
Improper Flow or Infusion	1	1
Moisture Damage	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	76	76
Burn(s)	6	7
Pain	6	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Seroma	5	5
Insufficient Information	5	5
Partial thickness (Second Degree) Burn	5	5
Full thickness (Third Degree) Burn	5	5
Swelling/ Edema	4	4
Bacterial Infection	4	4
Deformity/ Disfigurement	3	4
Skin Inflammation/ Irritation	2	2
Necrosis	2	2
Intraoperative Pain	1	1
Breast Mass	1	1
Blister	1	1
Post Operative Wound Infection	1	1
Foreign Body In Patient	1	1
Loss of Range of Motion	1	1
Scar Tissue	1	1
Laceration(s)	1	2
Abscess	1	1
Unspecified Tissue Injury	1	2
Subcutaneous Nodule	1	2
Bruise/Contusion	1	1