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
Material Puncture/Hole	24	24
Detachment of Device or Device Component	24	24
Break	19	19
Deflation Problem	16	16
Improper or Incorrect Procedure or Method	11	11
Suction Failure	9	9
Device Dislodged or Dislocated	8	8
Component Missing	8	8
Suction Problem	8	8
Material Integrity Problem	8	8
Fracture	7	7
Obstruction of Flow	6	6
Expulsion	5	5
Use of Device Problem	5	5
Defective Component	5	5
Appropriate Term/Code Not Available	4	4
Migration or Expulsion of Device	4	4
Decrease in Suction	4	4
Therapeutic or Diagnostic Output Failure	4	4
Defective Device	4	4
Positioning Failure	4	4
Material Split, Cut or Torn	4	4
Infusion or Flow Problem	3	3
Material Separation	3	3
Loose or Intermittent Connection	3	3
Unintended Deflation	3	3
Mechanical Problem	3	3
Device Damaged Prior to Use	3	3
Compatibility Problem	3	3
Component or Accessory Incompatibility	3	3
Component Incompatible	3	3
Loss of or Failure to Bond	3	3
Blocked Connection	2	2
Positioning Problem	2	2
Migration	2	2
Partial Blockage	2	2
Failure to Deflate	2	2
No Flow	2	2
Insufficient Information	2	2
Contamination /Decontamination Problem	2	2
Off-Label Use	2	2
Crack	2	2
Device Contaminated During Manufacture or Shipping	2	2
Difficult or Delayed Positioning	2	2
Material Deformation	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
Cough	2	2
Tachycardia	2	2
Shock	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
Multiple Organ Failure	1	1
Intermenstrual Bleeding	1	1
Exposure to Body Fluids	1	1
Micturition Urgency	1	1
Urinary Retention	1	1
Vomiting	1	1
Discomfort	1	1
Implant Pain	1	1
Perforation	1	1
Muscle Weakness	1	1
Fluid Discharge	1	1
Hematoma	1	1
Sepsis	1	1
Hypersensitivity/Allergic reaction	1	1
Pulmonary Edema	1	1
Anxiety	1	1
Bronchospasm	1	1
Miscarriage	1	1