Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
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
MDR Year
MDR Reports
MDR Events
2019
15085
15085
2020
16135
16135
2021
3725
3725
2022
1640
1640
2023
3637
3637
2024
390
390
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
36895
36895
Insufficient Information
6807
6807
Biocompatibility
2949
2949
Device Dislodged or Dislocated
2811
2811
Break
2265
2265
Migration
2073
2073
Expulsion
1279
1279
Appropriate Term/Code Not Available
457
457
Patient-Device Incompatibility
335
335
Patient Device Interaction Problem
271
271
Mechanical Problem
191
191
Material Integrity Problem
122
122
Migration or Expulsion of Device
76
76
Malposition of Device
59
59
Positioning Failure
45
45
Device Damaged by Another Device
36
36
Material Twisted/Bent
29
29
Activation Failure
27
27
Use of Device Problem
21
21
Material Fragmentation
18
18
Positioning Problem
18
18
Difficult to Remove
17
17
Difficult to Insert
13
13
Improper or Incorrect Procedure or Method
12
12
Therapeutic or Diagnostic Output Failure
12
12
Entrapment of Device
11
11
Activation, Positioning or Separation Problem
9
9
Device Handling Problem
8
8
Material Perforation
7
7
Separation Failure
7
7
Defective Device
6
6
Detachment of Device or Device Component
6
6
Off-Label Use
5
5
Product Quality Problem
4
4
Failure to Advance
4
4
Material Protrusion/Extrusion
4
4
No Pressure
3
3
Device Appears to Trigger Rejection
3
3
Nonstandard Device
2
2
Leak/Splash
2
2
Material Disintegration
2
2
Inaccurate Delivery
2
2
Output Problem
2
2
Unintended Movement
2
2
No Fail-Safe Mechanism
2
2
Packaging Problem
1
1
Gas/Air Leak
1
1
Physical Resistance/Sticking
1
1
Separation Problem
1
1
Lack of Effect
1
1
Contamination /Decontamination Problem
1
1
Expiration Date Error
1
1
Defective Component
1
1
Material Rupture
1
1
Unexpected Therapeutic Results
1
1
Unraveled Material
1
1
Burst Container or Vessel
1
1
Corroded
1
1
Fracture
1
1
Premature Activation
1
1
Material Puncture/Hole
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
14175
14175
No Code Available
13534
13534
Insufficient Information
4937
4937
Foreign Body In Patient
4471
4471
Uterine Perforation
3641
3641
Device Embedded In Tissue or Plaque
2480
2480
Heavier Menses
2376
2376
Hemorrhage/Bleeding
1881
1881
Abdominal Pain
1822
1822
Pelvic Inflammatory Disease
1260
1260
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1023
1023
No Clinical Signs, Symptoms or Conditions
1001
1001
Perforation
969
969
Genital Bleeding
925
925
Menstrual Irregularities
814
814
Fallopian Tube Perforation
669
669
Menorrhagia
642
642
Hypersensitivity/Allergic reaction
505
505
Ectopic Pregnancy
361
361
Headache
358
358
Fatigue
329
329
Weight Changes
249
249
Hair Loss
216
216
Pregnancy
210
210
Internal Organ Perforation
202
202
Arthralgia
152
152
Pregnancy with a Contraceptive Device
147
147
Rash
145
145
Abdominal Distention
136
136
Depression
131
131
Unspecified Infection
114
114
Nausea
107
107
Anxiety
106
106
Cramp(s)
97
97
Premature Labor
95
95
Urinary Tract Infection
92
92
Bowel Perforation
90
90
Emotional Changes
89
89
Abnormal Vaginal Discharge
84
84
Inflammation
78
78
Abdominal Cramps
75
75
No Information
71
71
Anemia
66
66
Abortion
64
64
Cyst(s)
60
60
Myalgia
59
59
Intermenstrual Bleeding
57
57
Failure of Implant
57
57
Itching Sensation
57
57
No Known Impact Or Consequence To Patient
56
56
Injury
55
55
Discomfort
48
48
Dyspareunia
44
44
Autoimmune Disorder
44
44
Dizziness
43
43
Memory Loss/Impairment
41
41
Complaint, Ill-Defined
39
39
Urticaria
38
38
Swelling
38
38
Sleep Dysfunction
35
35
Death
33
33
Confusion/ Disorientation
32
32
Death, Intrauterine Fetal
31
31
Miscarriage
30
30
Numbness
30
30
Visual Impairment
29
29
Erosion
28
28
Fungal Infection
28
28
Cognitive Changes
28
28
Constipation
25
25
Adhesion(s)
24
24
Unspecified Gastrointestinal Problem
23
23
Blurred Vision
23
23
Vomiting
23
23
Hot Flashes/Flushes
21
21
Sensitivity of Teeth
21
21
Abscess
21
21
Thyroid Problems
21
21
Local Reaction
21
21
Patient Problem/Medical Problem
20
20
Unspecified Reproductive System or Breast Problem
19
19
High Blood Pressure/ Hypertension
19
19
Sepsis
18
18
Reaction
18
18
Autoimmune Reaction
17
17
Incontinence
16
16
Laceration(s)
16
16
Tingling
16
16
Urinary Frequency
16
16
Sweating
15
15
Palpitations
15
15
Spontaneous Abortion
15
15
Cramp(s) /Muscle Spasm(s)
15
15
Vertigo
15
15
Skin Irritation
14
14
Ambulation Difficulties
14
14
Weakness
14
14
Visual Disturbances
13
13
Thrombus
12
12
Bacterial Infection
12
12
-
-