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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
MILLENNIUM MEDICAL TECHNOLOGIES INC (DBA CELLMYX)
  SUBSTANTIALLY EQUIVALENT 1
SYNTR HEALTH TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 28 28
2022 50 51
2023 15 16
2024 5 5
2025 10 10
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 22 23
Leak/Splash 19 19
Break 14 14
Failure to Power Up 10 10
Mechanical Problem 5 5
Energy Output Problem 4 4
Insufficient Device Problem Information 4 4
Activation Failure 4 4
Suction Failure 3 3
Failure to Deliver Energy 2 2
Output Problem 2 2
Wireless Communication Problem 2 2
Pumping Stopped 2 2
Use of Device Problem 2 2
Material Twisted/Bent 2 2
Infusion or Flow Problem 2 2
Device Emits Odor 2 2
Fitting Problem 1 1
Activation, Positioning or Separation Problem 1 1
Device Contamination with Body Fluid 1 1
Crack 1 1
Filtration Problem 1 1
Defective Component 1 1
Failure to Deliver 1 1
Degraded 1 1
Component Missing 1 1
Obstruction of Flow 1 1
Date/Time-Related Software Problem 1 1
Product Quality Problem 1 1
Suction Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 77 77
Burn(s) 6 7
Pain 6 7
Seroma 5 5
Insufficient Information 5 5
Partial thickness (Second Degree) Burn 5 5
Full thickness (Third Degree) Burn 5 5
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 5 5
Swelling/ Edema 4 4
Bacterial Infection 4 4
Deformity/ Disfigurement 3 4
Necrosis 2 2
Skin Inflammation/ Irritation 2 2
Breast Mass 1 1
Intraoperative Pain 1 1
Blister 1 1
Post Operative Wound Infection 1 1
Foreign Body In Patient 1 1
Loss of Range of Motion 1 1
Laceration(s) 1 2
Scar Tissue 1 1
Abscess 1 1
Unspecified Tissue Injury 1 2
Subcutaneous Nodule 1 2
Bruise/Contusion 1 1

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