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TPLC
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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
5950
5950
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
223
223
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
53386
53386
Insufficient Information
15620
15620
Patient-Device Incompatibility
5466
5466
Biocompatibility
5300
5300
Device Dislodged or Dislocated
5182
5182
Break
4740
4740
Migration
4628
4628
Migration or Expulsion of Device
3226
3226
Appropriate Term/Code Not Available
2257
2257
Expulsion
2218
2218
Device Operates Differently Than Expected
946
946
Patient Device Interaction Problem
417
417
Malposition of Device
378
378
Difficult to Remove
339
339
Difficult to Insert
325
325
Mechanical Problem
278
278
Material Integrity Problem
184
184
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
Detachment of Device or Device Component
68
68
Device Damaged by Another Device
68
68
Use of Device Problem
58
58
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
Unraveled Material
25
25
Difficult To Position
25
25
Unintended Movement
25
25
Component Falling
22
22
Failure to Advance
18
18
Uncoiled
16
16
Device Handling Problem
16
16
Metal Shedding Debris
14
14
Misfire
13
13
Material Deformation
13
13
Device Slipped
13
13
Premature Activation
13
13
Kinked
12
12
Material Rupture
12
12
Material Disintegration
10
10
No Pressure
10
10
Split
9
9
Retraction Problem
9
9
Partial Blockage
9
9
Loose or Intermittent Connection
9
9
Contamination
8
8
Device Contamination with Chemical or Other Material
8
8
Physical Resistance
7
7
Material Puncture/Hole
7
7
Off-Label Use
6
6
Coiled
6
6
Difficult to Advance
6
6
Physical Property Issue
6
6
Failure to Disconnect
5
5
Material Erosion
5
5
Unintended Collision
5
5
Leak/Splash
4
4
Device Expiration Issue
4
4
Material Frayed
4
4
Structural Problem
4
4
Microbial Contamination of Device
4
4
Inadequate Instructions for Non-Healthcare Professional
4
4
Physical Resistance/Sticking
4
4
Protective Measures Problem
3
3
Material Distortion
3
3
Output Problem
3
3
Folded
3
3
Device Damaged Prior to Use
3
3
Obstruction of Flow
3
3
Device Displays Incorrect Message
3
3
Failure to Fire
3
3
Burst Container or Vessel
3
3
Nonstandard Device
3
3
Device Emits Odor
2
2
Inadequate or Insufficient Training
2
2
Crack
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
35967
35976
No Code Available
17581
17584
Abdominal Pain
11860
11864
Heavier Menses
11216
11222
Foreign Body In Patient
8534
8534
Hemorrhage/Bleeding
8526
8526
Headache
8331
8336
Uterine Perforation
7479
7480
Fatigue
6959
6965
Menstrual Irregularities
6254
6256
Weight Changes
5839
5842
Insufficient Information
5068
5068
Hair Loss
4939
4944
Device Embedded In Tissue or Plaque
4549
4549
Depression
3913
3918
Cramp(s)
3094
3098
Rash
2869
2871
Hypersensitivity/Allergic reaction
2826
2826
Anxiety
2773
2777
Abdominal Distention
2554
2554
Perforation
2496
2497
Abdominal Cramps
2425
2425
Pelvic Inflammatory Disease
2238
2238
Swelling
2111
2112
Arthralgia
2101
2102
Emotional Changes
2076
2077
Unspecified Infection
2036
2037
Nausea
1996
1997
Dizziness
1689
1690
Memory Loss/Impairment
1623
1624
Cyst(s)
1606
1607
Pregnancy
1603
1606
Abnormal Vaginal Discharge
1497
1498
Itching Sensation
1332
1333
Complaint, Ill-Defined
1308
1310
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1307
1307
No Clinical Signs, Symptoms or Conditions
1258
1258
Inflammation
1227
1229
Discomfort
1222
1222
Genital Bleeding
1219
1219
Numbness
1144
1148
Urinary Tract Infection
1018
1019
Sleep Dysfunction
1011
1012
Internal Organ Perforation
885
885
Sweating
849
850
Fallopian Tube Perforation
836
836
Ectopic Pregnancy
831
831
Reaction
807
807
Menorrhagia
784
784
Disability
741
741
Confusion/ Disorientation
740
740
Tissue Damage
740
740
Tingling
725
727
Hot Flashes/Flushes
699
700
Intermenstrual Bleeding
687
687
Flatus
663
663
Anemia
661
661
Autoimmune Disorder
635
636
Failure of Implant
588
589
Blurred Vision
571
571
Muscle Spasm(s)
560
561
Vomiting
553
555
No Known Impact Or Consequence To Patient
536
536
Cognitive Changes
519
520
Constipation
516
516
Urticaria
473
474
Myalgia
468
468
Palpitations
467
467
Visual Impairment
463
463
High Blood Pressure/ Hypertension
463
463
Burning Sensation
459
460
Injury
450
450
Miscarriage
442
443
No Information
438
438
Ambulation Difficulties
433
433
Incontinence
423
423
Inadequate Pain Relief
391
391
Fungal Infection
384
384
Chest Pain
371
371
Test Result
370
371
Diarrhea
369
369
Thyroid Problems
365
365
Weakness
335
336
Bacterial Infection
323
323
Fever
294
294
Thrombus
282
283
Malaise
273
273
Toxicity
272
272
Skin Irritation
270
270
Dyspnea
270
270
Vertigo
264
264
Irritability
250
250
Fibrosis
249
249
Sensitivity of Teeth
247
247
Urinary Frequency
242
242
Tinnitus
242
242
Adhesion(s)
238
239
Autoimmune Reaction
234
234
Bruise/Contusion
219
219
Arthritis
214
214
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