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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
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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