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