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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, penis, inflatable
Definition PMAs to be filed by 7/11/00 (65 FR 19658 (4/12/00))
Product CodeJCW
Regulation Number 876.3350
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023
9 20 12 5 5 6

MDR Year MDR Reports MDR Events
2018 4 4
2019 5 5
2020 6 6
2021 22 22
2022 14 14
2023 4 4

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 5 5
Appropriate Term/Code Not Available 4 4
Insufficient Information 3 3
Material Protrusion/Extrusion 3 3
Output Problem 2 2
Positioning Problem 2 2
Material Erosion 2 2
Migration 2 2
Microbial Contamination of Device 2 2
Break 2 2
Deflation Problem 1 1
Flushing Problem 1 1
Kinked 1 1
Leak/Splash 1 1
Defective Device 1 1
Malposition of Device 1 1
Device Operates Differently Than Expected 1 1
Migration or Expulsion of Device 1 1
Material Puncture/Hole 1 1
Inadequacy of Device Shape and/or Size 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 18 18
Pain 8 8
No Known Impact Or Consequence To Patient 6 6
Insufficient Information 5 5
Unspecified Infection 4 4
Failure of Implant 3 3
Incontinence 3 3
Skin Erosion 2 2
Urinary Retention 2 2
Erythema 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
Foreign Body In Patient 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Code Available 1 1
Solid Tumour 1 1
Urinary Incontinence 1 1
Fever 1 1
Fistula 1 1
Hemorrhage/Bleeding 1 1
Failure to Anastomose 1 1
Erosion 1 1
Bruise/Contusion 1 1
Capsular Contracture 1 1
Cellulitis 1 1
Purulent Discharge 1 1
Urinary Tract Infection 1 1
Sepsis 1 1
Inflammation 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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