Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
prosthesis, penile
Product Code
FAE
Regulation Number
876.3630
Device Class
2
Premarket Reviews
Manufacturer
Decision
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
1. K183619
Tactra Penile Prosthesis, 9.5 mm Device, Tactra Pe
...
RIGICON INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
221
221
2020
163
163
2021
167
167
2022
168
168
2023
160
160
2024
35
35
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
352
352
Adverse Event Without Identified Device or Use Problem
229
229
Inadequacy of Device Shape and/or Size
76
76
Mechanical Problem
71
71
Defective Device
56
56
Migration
50
50
Fracture
29
29
Malposition of Device
26
26
Break
18
18
Material Puncture/Hole
13
13
Appropriate Term/Code Not Available
10
10
Use of Device Problem
9
9
Fluid/Blood Leak
6
6
Material Erosion
5
5
Device Appears to Trigger Rejection
5
5
Positioning Problem
5
5
Material Too Soft/Flexible
4
4
Material Protrusion/Extrusion
3
3
No Apparent Adverse Event
3
3
Noise, Audible
3
3
Difficult to Insert
3
3
Migration or Expulsion of Device
3
3
Inflation Problem
2
2
Material Deformation
2
2
Device Dislodged or Dislocated
2
2
Patient Device Interaction Problem
2
2
Material Twisted/Bent
2
2
Missing Information
1
1
Pumping Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Device Contamination with Chemical or Other Material
1
1
Patient-Device Incompatibility
1
1
Detachment of Device or Device Component
1
1
Device Markings/Labelling Problem
1
1
Crack
1
1
Deflation Problem
1
1
Degraded
1
1
Material Discolored
1
1
Peeled/Delaminated
1
1
Material Too Rigid or Stiff
1
1
Microbial Contamination of Device
1
1
Component Missing
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
243
243
No Known Impact Or Consequence To Patient
193
193
Unspecified Infection
125
125
Pain
99
99
Erosion
88
88
Perforation
55
55
Discomfort
38
38
Insufficient Information
33
33
No Information
32
32
No Consequences Or Impact To Patient
29
29
Bacterial Infection
19
19
Inflammation
10
10
Wound Dehiscence
10
10
Skin Erosion
9
9
Necrosis
8
8
Hematoma
7
7
Swelling/ Edema
7
7
Purulent Discharge
6
6
Unspecified Tissue Injury
5
5
Fluid Discharge
4
4
Complaint, Ill-Defined
4
4
Deformity/ Disfigurement
4
4
Scarring
4
4
Fistula
4
4
Failure of Implant
4
4
Tissue Damage
3
3
Irritation
3
3
Injury
3
3
Post Operative Wound Infection
3
3
No Patient Involvement
2
2
Depression
2
2
Numbness
2
2
Fungal Infection
2
2
Skin Inflammation/ Irritation
2
2
Sexual Dysfunction
2
2
Hemorrhage/Bleeding
2
2
Hypersensitivity/Allergic reaction
2
2
Fever
2
2
Edema
2
2
Abscess
2
2
Urinary Retention
2
2
Urinary Tract Infection
2
2
Burning Sensation
2
2
Swelling
1
1
Ulcer
1
1
Urinary Frequency
1
1
Pocket Erosion
1
1
Rash
1
1
Scar Tissue
1
1
Bruise/Contusion
1
1
Emotional Changes
1
1
Ecchymosis
1
1
Myocardial Infarction
1
1
Localized Skin Lesion
1
1
Obstruction/Occlusion
1
1
Sensitivity of Teeth
1
1
Sweating
1
1
Impaired Healing
1
1
Fibrosis
1
1
No Code Available
1
1
Urethral Stenosis/Stricture
1
1
Unspecified Kidney or Urinary Problem
1
1
Dyspareunia
1
1
-
-