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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 6 3 4 3 5 7 11 19 9 20 12 5 5 7 0

MDR Year MDR Reports MDR Events
2014 2 2
2015 3 3
2016 5 5
2017 3 3
2018 4 4
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 10 10
Fracture 8 8
Pumping Problem 6 6
Inflation Problem 5 5
Mechanical Problem 5 5
Device Operates Differently Than Expected 5 5
Material Erosion 4 4
Appropriate Term/Code Not Available 4 4
Material Protrusion/Extrusion 3 3
Insufficient Information 3 3
Output Problem 2 2
Positioning Problem 2 2
Migration 2 2
Leak/Splash 2 2
Break 2 2
Extrusion 2 2
Microbial Contamination of Device 2 2
Defective Device 1 1
Malposition of Device 1 1
Migration or Expulsion of Device 1 1
Material Puncture/Hole 1 1
Material Rupture 1 1
Inadequacy of Device Shape and/or Size 1 1
Deflation Problem 1 1
Degraded 1 1
Flushing Problem 1 1
Kinked 1 1
Material Split, Cut or Torn 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Mechanics Altered 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19 19
Pain 11 11
No Known Impact Or Consequence To Patient 10 10
Failure of Implant 6 6
Insufficient Information 6 6
Unspecified Infection 5 5
Incontinence 3 3
Erosion 3 3
Erythema 3 3
No Code Available 3 3
Urinary Retention 3 3
Urinary Tract Infection 2 2
Post Operative Wound Infection 2 2
Fluid Discharge 2 2
No Consequences Or Impact To Patient 2 2
Cellulitis 2 2
Inflammation 2 2
Skin Erosion 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Sepsis 1 1
Purulent Discharge 1 1
Fever 1 1
Fistula 1 1
Hemorrhage/Bleeding 1 1
Bruise/Contusion 1 1
Capsular Contracture 1 1
Failure to Anastomose 1 1
Wound Dehiscence 1 1
Bacterial Infection 1 1
Rupture 1 1
Discharge 1 1
Hernia 1 1
Discomfort 1 1
Depression 1 1
Impaired Healing 1 1
Obstruction/Occlusion 1 1
Foreign Body In Patient 1 1
Weakness 1 1
Solid Tumour 1 1
Urinary Incontinence 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Medical Systems II Jun-25-2015
2 American Medical Systems, Inc. II Nov-13-2014
3 Boston Scientific Corporation II Apr-16-2021
4 Boston Scientific Corporation II Nov-06-2020
5 Boston Scientific Corporation II Jan-28-2020
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