Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
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 Back to Search Results
Device transcervical contraceptive tubal occlusion device
Definition Call for PMAs 12/30/87 (52 FR 36883 10/1/87))
Product CodeHHS
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
Separation Failure 7 7
Material Perforation 7 7
Defective Device 6 6
Detachment of Device or Device Component 6 6
Off-Label Use 5 5
Material Protrusion/Extrusion 4 4
Failure to Advance 4 4
Product Quality Problem 4 4
Device Appears to Trigger Rejection 3 3
No Pressure 3 3
Unintended Movement 2 2
Leak/Splash 2 2
Output Problem 2 2
No Fail-Safe Mechanism 2 2
Nonstandard Device 2 2
Inaccurate Delivery 2 2
Material Disintegration 2 2
Fracture 1 1
Burst Container or Vessel 1 1
Gas/Air Leak 1 1
Expiration Date Error 1 1
Defective Component 1 1
Corroded 1 1
Unexpected Therapeutic Results 1 1
Material Puncture/Hole 1 1
Contamination /Decontamination Problem 1 1
Lack of Effect 1 1
Unraveled Material 1 1
Separation Problem 1 1
Premature Activation 1 1
Packaging Problem 1 1
Material Rupture 1 1
Physical Resistance/Sticking 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
Failure of Implant 57 57
Intermenstrual Bleeding 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
Numbness 30 30
Miscarriage 30 30
Visual Impairment 29 29
Fungal Infection 28 28
Cognitive Changes 28 28
Erosion 28 28
Constipation 25 25
Adhesion(s) 24 24
Blurred Vision 23 23
Unspecified Gastrointestinal Problem 23 23
Vomiting 23 23
Abscess 21 21
Local Reaction 21 21
Thyroid Problems 21 21
Hot Flashes/Flushes 21 21
Sensitivity of Teeth 21 21
Patient Problem/Medical Problem 20 20
Unspecified Reproductive System or Breast Problem 19 19
High Blood Pressure/ Hypertension 19 19
Reaction 18 18
Sepsis 18 18
Autoimmune Reaction 17 17
Urinary Frequency 16 16
Tingling 16 16
Incontinence 16 16
Laceration(s) 16 16
Cramp(s) /Muscle Spasm(s) 15 15
Palpitations 15 15
Spontaneous Abortion 15 15
Vertigo 15 15
Sweating 15 15
Skin Irritation 14 14
Ambulation Difficulties 14 14
Weakness 14 14
Visual Disturbances 13 13
Fever 12 12
Thrombus 12 12

-
-