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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
Wireless Communication Problem 2 2
Use of Device Problem 2 2
Pumping Stopped 2 2
Infusion or Flow Problem 2 2
Device Emits Odor 2 2
Material Twisted/Bent 2 2
Output Problem 2 2
Failure to Deliver Energy 2 2
Component Missing 1 1
Filtration Problem 1 1
Device Contamination with Body Fluid 1 1
Fitting Problem 1 1
Degraded 1 1
Crack 1 1
Date/Time-Related Software Problem 1 1
Failure to Deliver 1 1
Defective Component 1 1
Activation, Positioning or Separation Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Suction Problem 1 1
Product Quality Problem 1 1
Obstruction of Flow 1 1

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

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