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TPLC
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Device
prosthesis, penis, inflatable
Definition
PMAs to be filed by 7/11/00 (65 FR 19658 (4/12/00))
Product Code
JCW
Regulation Number
876.3350
Device Class
3
Premarket Approvals (PMA)
2019
2020
2021
2022
2023
2024
20
12
5
5
7
0
MDR Year
MDR Reports
MDR Events
2019
5
5
2020
6
6
2021
22
22
2022
14
14
2023
4
4
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
8
8
Fracture
8
8
Pumping Problem
6
6
Inflation Problem
5
5
Mechanical Problem
4
4
Material Protrusion/Extrusion
3
3
Insufficient Information
3
3
Appropriate Term/Code Not Available
3
3
Migration
2
2
Output Problem
2
2
Positioning Problem
2
2
Break
2
2
Deflation Problem
1
1
Material Erosion
1
1
Flushing Problem
1
1
Migration or Expulsion of Device
1
1
Material Puncture/Hole
1
1
Inadequacy of Device Shape and/or Size
1
1
Microbial Contamination of Device
1
1
Defective Device
1
1
Malposition of Device
1
1
Leak/Splash
1
1
Material Split, Cut or Torn
1
1
Therapeutic or Diagnostic Output Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
19
19
Pain
9
9
Insufficient Information
6
6
No Known Impact Or Consequence To Patient
5
5
Failure of Implant
5
5
Incontinence
3
3
Unspecified Infection
2
2
Erythema
2
2
Skin Erosion
2
2
Urinary Retention
2
2
Urinary Tract Infection
2
2
No Consequences Or Impact To Patient
2
2
Rupture
1
1
Discharge
1
1
Hernia
1
1
Discomfort
1
1
Depression
1
1
Impaired Healing
1
1
Obstruction/Occlusion
1
1
Post Operative Wound Infection
1
1
Fluid Discharge
1
1
Foreign Body In Patient
1
1
Fever
1
1
Fistula
1
1
Hemorrhage/Bleeding
1
1
Failure to Anastomose
1
1
Bacterial Infection
1
1
Erosion
1
1
Bruise/Contusion
1
1
Capsular Contracture
1
1
Cellulitis
1
1
Purulent Discharge
1
1
Inflammation
1
1
Solid Tumour
1
1
Urinary Incontinence
1
1
Sepsis
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Corporation
II
Apr-16-2021
2
Boston Scientific Corporation
II
Nov-06-2020
3
Boston Scientific Corporation
II
Jan-28-2020
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