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	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
Detachment Of Device Component	106	106
Device Appears to Trigger Rejection	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
Material Twisted/Bent	89	89
Improper or Incorrect Procedure or Method	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	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