TPLC - Total Product Life Cycle

• 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