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TPLC
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Device
tissue expander and accessories
Product Code
LCJ
Device Class
Unclassified
Premarket Reviews
Manufacturer
Decision
MENTOR WORLDWIDE LLC
SUBSTANTIALLY EQUIVALENT
2
MOTIVA USA LLC
SUBSTANTIALLY EQUIVALENT
1
SIENTRA, INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2020
639
639
2021
438
438
2022
499
499
2023
478
478
2024
490
490
2025
31
31
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Rupture
1102
1102
Adverse Event Without Identified Device or Use Problem
580
580
Fluid/Blood Leak
379
379
Device Appears to Trigger Rejection
114
114
Off-Label Use
74
74
Break
64
64
Patient-Device Incompatibility
48
48
Deflation Problem
40
40
Migration
34
34
Defective Device
34
34
Improper or Incorrect Procedure or Method
28
28
Device Handling Problem
27
27
Connection Problem
21
21
Use of Device Problem
21
21
Device Contamination with Chemical or Other Material
17
17
Appropriate Term/Code Not Available
16
16
Infusion or Flow Problem
15
15
Device Contaminated During Manufacture or Shipping
15
15
No Apparent Adverse Event
13
13
Difficult to Open or Remove Packaging Material
10
10
Leak/Splash
9
9
Filling Problem
9
9
Defective Component
9
9
Unintended Deflation
9
9
Peeled/Delaminated
9
9
Inflation Problem
8
8
Detachment of Device or Device Component
7
7
Material Deformation
6
6
Component Missing
6
6
Material Separation
5
5
Packaging Problem
5
5
Material Integrity Problem
4
4
Shipping Damage or Problem
4
4
Unsealed Device Packaging
4
4
Nonstandard Device
4
4
Expiration Date Error
3
3
Insufficient Information
3
3
Patient Device Interaction Problem
3
3
Biofilm coating in Device
2
2
Device-Device Incompatibility
2
2
Material Puncture/Hole
2
2
Material Discolored
2
2
Device Damaged Prior to Use
2
2
Device Dislodged or Dislocated
2
2
Gel Leak
2
2
Collapse
2
2
Expulsion
1
1
Contamination /Decontamination Problem
1
1
Solder Joint Fracture
1
1
Microbial Contamination of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Deformity/ Disfigurement
664
664
Failure of Implant
482
482
No Code Available
299
299
Unspecified Infection
277
277
No Clinical Signs, Symptoms or Conditions
215
215
Seroma
164
164
Capsular Contracture
144
144
Post Operative Wound Infection
105
105
Necrosis
77
77
Insufficient Information
64
64
No Consequences Or Impact To Patient
48
48
Wound Dehiscence
43
43
No Patient Involvement
40
40
Pain
35
35
Hematoma
34
35
Foreign Body Reaction
30
30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
28
28
Breast Discomfort/Pain
27
27
Impaired Healing
26
26
Local Reaction
23
23
No Known Impact Or Consequence To Patient
21
21
Cellulitis
21
21
Rupture
19
19
Bacterial Infection
19
19
Lymphoma
17
17
Pocket Erosion
15
15
Swollen Lymph Nodes/Glands
15
15
Erythema
15
15
Cancer
13
13
Erosion
11
11
Swelling/ Edema
10
10
Hypersensitivity/Allergic reaction
10
10
Inflammation
10
10
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL)
10
10
Wrinkling
9
9
Fluid Discharge
9
9
Fatigue
8
8
Unspecified Tissue Injury
8
8
Fever
7
7
Autoimmune Disorder
7
7
Scar Tissue
6
6
Myalgia
6
6
Breast Cancer
6
6
Arthralgia
5
5
Memory Loss/Impairment
5
5
Rash
5
5
Abscess
5
5
Hemorrhage/Bleeding
4
4
Burning Sensation
4
4
Numbness
4
4
Recalls
Manufacturer
Recall Class
Date Posted
1
B. Braun Medical, Inc.
II
Nov-03-2023
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