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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implanted fecal incontinence device
Definition PMA Approved: P010020
Product CodeMIP
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
3 4 1 6 1 1 4 1 0 0 0 0 0 0 0 0

MDR Year MDR Reports MDR Events
2014 46 46
2015 33 33
2016 1 1
2017 1 1
2018 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 25 25
Fluid/Blood Leak 18 18
Insufficient Information 14 14
Leak/Splash 14 14
Mechanical Problem 6 6
Device Operates Differently Than Expected 5 5
Extrusion 2 2
Inadequacy of Device Shape and/or Size 2 2
Failure of Device to Self-Test 1 1
Material Deformation 1 1
Device Slipped 1 1
Material Erosion 1 1
Malposition of Device 1 1
Appropriate Term/Code Not Available 1 1
Device Operational Issue 1 1
Migration or Expulsion of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Incontinence 27 27
Failure of Implant 23 23
Unspecified Infection 18 18
No Information 8 8
Erosion 5 5
No Known Impact Or Consequence To Patient 4 4
No Code Available 2 2
Constipation 2 2
Sepsis 2 2
Abdominal Pain 2 2
Purulent Discharge 2 2
Adhesion(s) 2 2
Pain 2 2
Perforation 1 1
Pocket Erosion 1 1
Inflammation 1 1
Nausea 1 1
Internal Organ Perforation 1 1
Erythema 1 1
Fever 1 1
Fistula 1 1
Micturition Urgency 1 1
Abscess 1 1
Diarrhea 1 1
Urinary Tract Infection 1 1
Abnormal Vaginal Discharge 1 1
Vomiting 1 1
Chills 1 1
Urinary Frequency 1 1
Discomfort 1 1
Obstruction/Occlusion 1 1
Abdominal Distention 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Medical Systems, Inc. II Jun-27-2011
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