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TPLC
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show TPLC since
2009
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2011
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2014
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2024
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Device
implanted fecal incontinence device
Definition
PMA Approved: P010020
Product Code
MIP
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
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
26
26
Fluid/Blood Leak
18
18
Leak/Splash
14
14
Insufficient Information
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
Device Slipped
1
1
Material Erosion
1
1
Material Deformation
1
1
Migration or Expulsion of Device
1
1
Malposition of Device
1
1
Device Operational Issue
1
1
Appropriate Term/Code Not Available
1
1
Failure of Device to Self-Test
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
6
6
No Known Impact Or Consequence To Patient
4
4
Abdominal Pain
2
2
No Code Available
2
2
Sepsis
2
2
Adhesion(s)
2
2
Purulent Discharge
2
2
Pain
2
2
Constipation
2
2
Patient Problem/Medical Problem
1
1
Nausea
1
1
Abnormal Vaginal Discharge
1
1
Inflammation
1
1
Perforation
1
1
Abdominal Distention
1
1
Obstruction/Occlusion
1
1
Fever
1
1
Chills
1
1
Diarrhea
1
1
Micturition Urgency
1
1
Vomiting
1
1
Erythema
1
1
Discomfort
1
1
Abscess
1
1
Urinary Frequency
1
1
Pocket Erosion
1
1
Internal Organ Perforation
1
1
Fistula
1
1
Urinary Tract Infection
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
American Medical Systems, Inc.
II
Jun-27-2011
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