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TPLC
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Device
tissue expander and accessories
Product Code
LCJ
Device Class
Unclassified
Premarket Reviews
Manufacturer
Decision
MOTIVA USA LLC
SUBSTANTIALLY EQUIVALENT
1
SIENTRA, INC.
SUBSTANTIALLY EQUIVALENT
2
1. K214124
AlloX2 Pro Tissue Expanders
2. K221127
Sientra, inc. Portfinder
MDR Year
MDR Reports
MDR Events
2019
546
546
2020
639
639
2021
438
438
2022
499
499
2023
478
478
2024
135
135
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Rupture
1201
1201
Adverse Event Without Identified Device or Use Problem
595
595
Fluid/Blood Leak
429
429
Device Appears to Trigger Rejection
105
105
Off-Label Use
94
94
Patient-Device Incompatibility
61
61
Break
52
52
Improper or Incorrect Procedure or Method
46
46
Deflation Problem
43
43
Defective Device
37
37
Migration
29
29
Device Contamination with Chemical or Other Material
28
28
Use of Device Problem
28
28
Device Handling Problem
23
23
Connection Problem
21
21
Inflation Problem
19
19
Appropriate Term/Code Not Available
17
17
Defective Component
15
15
No Apparent Adverse Event
13
13
Infusion or Flow Problem
13
13
Device Contaminated During Manufacture or Shipping
12
12
Detachment of Device or Device Component
11
11
Material Separation
11
11
Leak/Splash
8
8
Unintended Deflation
8
8
Insufficient Information
7
7
Peeled/Delaminated
7
7
Filling Problem
7
7
Unsealed Device Packaging
5
5
Nonstandard Device
5
5
Material Puncture/Hole
5
5
Component Missing
5
5
Packaging Problem
5
5
Material Deformation
5
5
Manufacturing, Packaging or Shipping Problem
4
4
Shipping Damage or Problem
4
4
Gel Leak
3
3
Material Discolored
3
3
Material Integrity Problem
3
3
Contamination /Decontamination Problem
3
3
Expiration Date Error
3
3
Patient Device Interaction Problem
2
2
Device Damaged by Another Device
2
2
Device-Device Incompatibility
2
2
Device Dislodged or Dislocated
2
2
Collapse
2
2
Biofilm coating in Device
2
2
Delivered as Unsterile Product
2
2
Unintended Ejection
1
1
Fracture
1
1
Inadequacy of Device Shape and/or Size
1
1
Product Quality Problem
1
1
Device Contamination with Body Fluid
1
1
Solder Joint Fracture
1
1
Malposition of Device
1
1
Device Damaged Prior to Use
1
1
Expulsion
1
1
Material Protrusion/Extrusion
1
1
Difficult to Open or Remove Packaging Material
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Contamination of Device Ingredient or Reagent
1
1
Activation Failure
1
1
Incomplete or Inadequate Connection
1
1
Missing Information
1
1
Therapeutic or Diagnostic Output Failure
1
1
Unintended Movement
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
577
577
Deformity/ Disfigurement
541
541
Failure of Implant
510
510
Unspecified Infection
294
294
No Clinical Signs, Symptoms or Conditions
161
161
Seroma
154
154
Capsular Contracture
153
153
Post Operative Wound Infection
86
86
No Consequences Or Impact To Patient
68
68
Necrosis
65
65
No Patient Involvement
64
64
Insufficient Information
58
58
Pain
43
43
No Known Impact Or Consequence To Patient
42
42
Wound Dehiscence
37
37
Hematoma
29
30
Foreign Body Reaction
24
24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
22
22
Cellulitis
21
21
Local Reaction
21
21
Breast Discomfort/Pain
20
20
Impaired Healing
19
19
Pocket Erosion
18
18
Bacterial Infection
15
15
Lymphoma
15
15
Swollen Lymph Nodes/Glands
14
14
Abscess
13
13
Rupture
12
12
Cancer
11
11
Fluid Discharge
10
10
Hypersensitivity/Allergic reaction
10
10
Swelling/ Edema
10
10
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL)
9
9
Inflammation
9
9
Erosion
9
9
Fatigue
8
8
Fever
8
8
Unspecified Tissue Injury
8
8
Scar Tissue
7
7
Wrinkling
7
7
Rash
6
6
Swelling
6
7
Itching Sensation
5
5
Memory Loss/Impairment
5
5
Erythema
5
5
Autoimmune Disorder
5
5
Autoimmune Reaction
4
4
Breast Cancer
4
4
Chest Pain
4
4
Headache
4
4
Foreign Body Sensation in Eye
4
4
Granuloma
4
4
Sepsis
4
4
Chills
4
4
Myalgia
4
4
Burning Sensation
4
4
Numbness
4
4
Arthralgia
4
4
Anxiety
4
4
Vomiting
3
3
Injury
3
3
Breast Mass
3
3
Weight Changes
3
3
Tissue Breakdown
3
3
Sleep Dysfunction
3
3
Dry Mouth
3
3
Unspecified Gastrointestinal Problem
3
3
Swollen Lymph Nodes
3
3
Skin Irritation
3
3
Nausea
3
3
Ischemia
3
3
High Blood Pressure/ Hypertension
3
3
Hemorrhage/Bleeding
3
3
Hair Loss
3
3
Diarrhea
3
3
Dry Eye(s)
3
3
Crushing Injury
3
3
Skin Disorders
3
3
Skin Inflammation/ Irritation
3
3
Cramp(s) /Muscle Spasm(s)
2
2
Localized Skin Lesion
2
2
Cyst(s)
2
2
Pulmonary Embolism
2
2
Anemia
2
2
Dyspnea
2
2
Edema
2
2
Pyrosis/Heartburn
2
2
Muscle Weakness
2
2
Skin Discoloration
2
2
Constipation
2
2
Paresthesia
2
2
Unspecified Mental, Emotional or Behavioural Problem
2
2
Not Applicable
2
2
No Information
2
2
Ambulation Difficulties
2
2
Cognitive Changes
2
2
Diaphoresis
2
2
Abdominal Distention
2
2
Sweating
2
2
Depression
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Allergan PLC
I
Sep-11-2019
2
B. Braun Medical, Inc.
II
Nov-03-2023
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