TPLC - Total Product Life Cycle

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Device	intrauterine tamponade balloon
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	400	400
Fluid/Blood Leak	285	285
Material Rupture	69	69
Inflation Problem	49	49
Leak/Splash	46	46
Detachment of Device or Device Component	24	24
Material Puncture/Hole	24	24
Break	19	19
Deflation Problem	16	16
Improper or Incorrect Procedure or Method	11	11
Suction Failure	9	9
Suction Problem	8	8
Device Dislodged or Dislocated	8	8
Material Integrity Problem	8	8
Component Missing	8	8
Fracture	7	7
Obstruction of Flow	6	6
Expulsion	5	5
Defective Component	5	5
Use of Device Problem	5	5
Material Split, Cut or Torn	4	4
Appropriate Term/Code Not Available	4	4
Defective Device	4	4
Therapeutic or Diagnostic Output Failure	4	4
Decrease in Suction	4	4
Positioning Failure	4	4
Migration or Expulsion of Device	4	4
Loose or Intermittent Connection	3	3
Component Incompatible	3	3
Infusion or Flow Problem	3	3
Unintended Deflation	3	3
Device Damaged Prior to Use	3	3
Mechanical Problem	3	3
Loss of or Failure to Bond	3	3
Material Separation	3	3
Component or Accessory Incompatibility	3	3
Compatibility Problem	3	3
Crack	2	2
Insufficient Information	2	2
Off-Label Use	2	2
Contamination /Decontamination Problem	2	2
Blocked Connection	2	2
Migration	2	2
Partial Blockage	2	2
Positioning Problem	2	2
Difficult or Delayed Positioning	2	2
Material Deformation	2	2
Failure to Deflate	2	2
No Flow	2	2
Device Contaminated During Manufacture or Shipping	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	347	347
Hemorrhage/Bleeding	227	227
Insufficient Information	182	182
No Consequences Or Impact To Patient	141	141
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	118	118
No Known Impact Or Consequence To Patient	49	49
Disseminated Intravascular Coagulation (DIC)	20	20
Blood Loss	19	19
Uterine Perforation	16	16
Laceration(s)	14	14
Foreign Body In Patient	9	9
Low Blood Pressure/ Hypotension	8	8
No Code Available	8	8
No Patient Involvement	8	8
No Information	7	7
Fever	7	7
Hypovolemic Shock	6	6
Thrombosis/Thrombus	6	6
Coagulation Disorder	4	4
Distress	2	2
Bacterial Infection	2	2
Swelling/ Edema	2	2
Shock	2	2
Cough	2	2
Tachycardia	2	2
Abscess	2	2
Pain	2	2
Rupture	2	2
Necrosis	2	2
Wound Dehiscence	2	2
Abdominal Pain	2	2
Pelvic Inflammatory Disease	1	1
Discomfort	1	1
Intermenstrual Bleeding	1	1
Vomiting	1	1
Exposure to Body Fluids	1	1
Micturition Urgency	1	1
Urinary Retention	1	1
Multiple Organ Failure	1	1
Perforation	1	1
Hematoma	1	1
Muscle Weakness	1	1
Fluid Discharge	1	1
Implant Pain	1	1
Bronchospasm	1	1
Pulmonary Edema	1	1
Sepsis	1	1
Anxiety	1	1
Hypersensitivity/Allergic reaction	1	1
Menstrual Irregularities	1	1