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U.S. Department of Health and Human Services

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 CodeMUU
Regulation Number 878.5040
Device Class 2


Premarket Reviews
ManufacturerDecision
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

MDR Year MDR Reports MDR Events
2020 36 36
2021 28 28
2022 50 50
2023 15 15
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 32 32
Break 25 25
Leak/Splash 10 10
Insufficient Information 9 9
Failure to Power Up 9 9
Mechanical Problem 6 6
Suction Failure 5 5
Activation Failure 4 4
Fracture 4 4
Fluid/Blood Leak 4 4
Energy Output Problem 4 4
Output Problem 4 4
Patient-Device Incompatibility 3 3
Material Twisted/Bent 3 3
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Pumping Stopped 2 2
Wireless Communication Problem 2 2
Power Problem 2 2
Device Emits Odor 2 2
Infusion or Flow Problem 2 2
Failure to Deliver Energy 2 2
Electrical /Electronic Property Problem 1 1
Defective Component 1 1
Activation, Positioning or Separation Problem 1 1
Unexpected Shutdown 1 1
Electrical Power Problem 1 1
Product Quality Problem 1 1
Defective Device 1 1
Date/Time-Related Software Problem 1 1
Suction Problem 1 1
Device Contamination with Body Fluid 1 1
Filtration Problem 1 1
Fitting Problem 1 1
Obstruction of Flow 1 1
Component Missing 1 1
Detachment of Device or Device Component 1 1
Crack 1 1
Degraded 1 1
Failure to Deliver 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 73 73
Burn(s) 10 10
No Patient Involvement 7 7
Seroma 7 7
No Consequences Or Impact To Patient 7 7
Pain 7 7
Partial thickness (Second Degree) Burn 7 7
Necrosis 6 6
No Code Available 6 6
Full thickness (Third Degree) Burn 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Insufficient Information 5 5
Bacterial Infection 4 4
Swelling/ Edema 4 4
Scar Tissue 3 3
Foreign Body In Patient 3 3
Deformity/ Disfigurement 3 3
Skin Inflammation/ Irritation 2 2
Blister 2 2
Impaired Healing 2 2
Cyst(s) 1 1
Ambulation Difficulties 1 1
Bruise/Contusion 1 1
Scarring 1 1
Loss of Range of Motion 1 1
Subcutaneous Nodule 1 1
Breast Mass 1 1
Post Operative Wound Infection 1 1
Swelling 1 1
No Known Impact Or Consequence To Patient 1 1
Unspecified Tissue Injury 1 1
Laceration(s) 1 1
Abscess 1 1
Intraoperative Pain 1 1

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