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TPLC
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show TPLC since
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Device
transcervical contraceptive tubal occlusion device
Definition
Call for PMAs 12/30/87 (52 FR 36883 10/1/87))
Product Code
HHS
Regulation Number
884.5380
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
7
2
2
7
1
1
2
5
1
2
0
0
0
0
0
0
MDR Year
MDR Reports
MDR Events
2014
2225
2225
2015
5951
5951
2016
4928
4928
2017
11847
11847
2018
5983
5983
2019
15085
15085
2020
16135
16135
2021
3725
3725
2022
1640
1640
2023
3637
3637
2024
558
558
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
53564
53564
Insufficient Information
15856
15856
Patient-Device Incompatibility
5467
5467
Biocompatibility
5357
5357
Device Dislodged or Dislocated
5238
5238
Break
4804
4804
Migration
4684
4684
Migration or Expulsion of Device
3226
3226
Appropriate Term/Code Not Available
2264
2264
Expulsion
2224
2224
Device Operates Differently Than Expected
946
946
Patient Device Interaction Problem
418
418
Malposition of Device
378
378
Difficult to Remove
339
339
Difficult to Insert
326
326
Mechanical Problem
278
278
Material Integrity Problem
186
186
Fracture
162
162
Material Fragmentation
159
159
Positioning Failure
146
146
Entrapment of Device
134
134
Unexpected Therapeutic Results
132
132
Positioning Problem
119
119
Extrusion
115
115
Device Appears to Trigger Rejection
106
106
Detachment Of Device Component
106
106
Activation, Positioning or Separation Problem
103
103
Therapeutic or Diagnostic Output Failure
94
94
Bent
92
92
Device Or Device Fragments Location Unknown
91
91
Improper or Incorrect Procedure or Method
89
89
Material Twisted/Bent
89
89
Device Inoperable
85
85
Material Protrusion/Extrusion
83
83
Defective Device
77
77
Separation Failure
74
74
Activation Failure
72
72
Product Quality Problem
70
70
Device Damaged by Another Device
68
68
Detachment of Device or Device Component
68
68
Use of Device Problem
59
59
Material Perforation
57
57
Difficult or Delayed Positioning
56
56
Sticking
49
49
Component Missing
41
41
Stretched
40
40
Material Separation
32
32
Occlusion Within Device
30
30
Defective Component
28
28
Unintended Movement
25
25
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
36120
36129
No Code Available
17582
17585
Abdominal Pain
11916
11920
Heavier Menses
11217
11223
Foreign Body In Patient
8580
8580
Hemorrhage/Bleeding
8531
8531
Headache
8343
8348
Uterine Perforation
7516
7517
Fatigue
6964
6970
Menstrual Irregularities
6264
6266
Weight Changes
5842
5845
Insufficient Information
5191
5191
Hair Loss
4941
4946
Device Embedded In Tissue or Plaque
4568
4568
Depression
3915
3920
Cramp(s)
3094
3098
Rash
2869
2871
Hypersensitivity/Allergic reaction
2843
2843
Anxiety
2774
2778
Abdominal Distention
2557
2557
Perforation
2523
2524
Abdominal Cramps
2426
2426
Pelvic Inflammatory Disease
2253
2253
Swelling
2111
2112
Arthralgia
2102
2103
Emotional Changes
2078
2079
Unspecified Infection
2036
2037
Nausea
1997
1998
Dizziness
1691
1692
Memory Loss/Impairment
1623
1624
Cyst(s)
1606
1607
Pregnancy
1603
1606
Abnormal Vaginal Discharge
1497
1498
Itching Sensation
1334
1335
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1313
1313
Complaint, Ill-Defined
1308
1310
Genital Bleeding
1273
1273
No Clinical Signs, Symptoms or Conditions
1261
1261
Inflammation
1227
1229
Discomfort
1224
1224
Numbness
1145
1149
Urinary Tract Infection
1018
1019
Sleep Dysfunction
1011
1012
Internal Organ Perforation
912
912
Fallopian Tube Perforation
864
864
Sweating
850
851
Ectopic Pregnancy
835
835
Menorrhagia
809
809
Reaction
807
807
Disability
742
742
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