TPLC - Total Product Life Cycle

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Device	intrauterine tamponade balloon
Regulation Description	Obstetric-gynecologic specialized manual instrument.
Definition	provides temporary control or reduction of postpartum uterine bleeding
Product Code	OQY
Regulation Number	884.4530
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	490	490
Fluid/Blood Leak	303	303
Material Rupture	57	57
Inflation Problem	31	31
Detachment of Device or Device Component	20	20
Leak/Splash	19	19
Break	17	17
Improper or Incorrect Procedure or Method	13	13
Material Integrity Problem	12	12
Fracture	11	11
Suction Failure	10	10
Material Puncture/Hole	10	10
Component Missing	9	9
Suction Problem	8	8
Obstruction of Flow	8	8
Component or Accessory Incompatibility	6	6
Component Incompatible	6	6
Compatibility Problem	6	6
Infusion or Flow Problem	6	6
Expulsion	5	5
Migration or Expulsion of Device	4	4
Mechanical Problem	4	4
Therapeutic or Diagnostic Output Failure	4	4
Material Separation	4	4
Positioning Failure	4	4
Decrease in Suction	4	4
Loose or Intermittent Connection	3	3
Unintended Deflation	3	3
Defective Device	3	3
Deflation Problem	3	3
Device Slipped	2	2
Failure to Deflate	2	2
Migration	2	2
Device Contaminated During Manufacture or Shipping	2	2
Difficult or Delayed Positioning	2	2
Use of Device Problem	2	2
Positioning Problem	2	2
Insufficient Information	2	2
Fitting Problem	1	1
Lack of Effect	1	1
Backflow	1	1
Patient Device Interaction Problem	1	1
Material Deformation	1	1
Packaging Problem	1	1
Difficult to Remove	1	1
Partial Blockage	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Appropriate Term/Code Not Available	1	1
Complete Blockage	1	1
Unexpected Therapeutic Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	534	534
Hemorrhage/Bleeding	270	270
Insufficient Information	237	237
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	119	119
Disseminated Intravascular Coagulation (DIC)	27	27
Uterine Perforation	21	21
Laceration(s)	17	17
Low Blood Pressure/ Hypotension	11	11
Foreign Body In Patient	11	11
Thrombosis/Thrombus	8	8
No Consequences Or Impact To Patient	7	7
Fever	7	7
Rupture	4	4
Coagulation Disorder	4	4
Abdominal Pain	4	4
Wound Dehiscence	4	4
Bacterial Infection	3	3
Cough	3	3
Necrosis	2	2
Distress	2	2
Hypovolemic Shock	2	2
Obstruction/Occlusion	2	2
Cardiac Arrest	2	2
Perforation of Vessels	2	2
Arthralgia	2	2
Swelling/ Edema	2	2
Shock	2	2
Tachycardia	2	2
Pain	2	2
Abscess	2	2
Device Embedded In Tissue or Plaque	1	1
Unspecified Reproductive System or Breast Problem	1	1
Cervical Changes	1	1
Damage to Ligament(s)	1	1
Organ Dehiscence	1	1
Anxiety	1	1
Pulmonary Edema	1	1
Bronchospasm	1	1
Fluid Discharge	1	1
Prolapse	1	1
Menstrual Irregularities	1	1
Liver Failure	1	1
Urinary Retention	1	1
Micturition Urgency	1	1
Exposure to Body Fluids	1	1
Vomiting	1	1
Hypersensitivity/Allergic reaction	1	1
Sepsis	1	1
Pelvic Inflammatory Disease	1	1
Reaction to Medicinal Component of Device	1	1