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	486	486
Fluid/Blood Leak	343	343
Material Rupture	69	69
Inflation Problem	34	34
Detachment of Device or Device Component	21	21
Leak/Splash	20	20
Break	19	19
Material Puncture/Hole	14	14
Improper or Incorrect Procedure or Method	12	12
Material Integrity Problem	12	12
Fracture	11	11
Component Missing	10	10
Suction Failure	9	9
Suction Problem	8	8
Device Dislodged or Dislocated	7	7
Obstruction of Flow	7	7
Infusion or Flow Problem	6	6
Component or Accessory Incompatibility	5	5
Expulsion	5	5
Compatibility Problem	5	5
Component Incompatible	5	5
Loose or Intermittent Connection	4	4
Material Separation	4	4
Decrease in Suction	4	4
Positioning Failure	4	4
Therapeutic or Diagnostic Output Failure	4	4
Defective Device	4	5
Migration or Expulsion of Device	4	4
Mechanical Problem	4	4
Material Split, Cut or Torn	4	4
Deflation Problem	3	3
Use of Device Problem	3	3
Unintended Deflation	3	3
Device Damaged Prior to Use	3	3
Contamination /Decontamination Problem	2	2
Positioning Problem	2	2
Defective Component	2	2
Insufficient Information	2	2
Difficult or Delayed Positioning	2	2
Migration	2	2
Failure to Deflate	2	2
Device Contaminated During Manufacture or Shipping	2	2
Device Slipped	2	2
Difficult to Remove	1	1
Patient Device Interaction Problem	1	1
Difficult to Insert	1	2
Manufacturing, Packaging or Shipping Problem	1	1
Backflow	1	1
Material Twisted/Bent	1	1
Lack of Effect	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	523	523
Hemorrhage/Bleeding	279	279
Insufficient Information	236	236
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	119	119
No Consequences Or Impact To Patient	62	62
Disseminated Intravascular Coagulation (DIC)	26	26
Uterine Perforation	20	20
Laceration(s)	17	17
No Known Impact Or Consequence To Patient	12	12
Low Blood Pressure/ Hypotension	10	10
Foreign Body In Patient	9	9
Thrombosis/Thrombus	8	8
Blood Loss	8	9
Fever	7	7
Abdominal Pain	4	4
Wound Dehiscence	4	4
Coagulation Disorder	4	4
Rupture	4	4
Cough	3	3
No Information	3	3
Distress	2	2
Bacterial Infection	2	2
Swelling/ Edema	2	2
Perforation of Vessels	2	2
Tachycardia	2	2
Shock	2	2
Abscess	2	2
No Patient Involvement	2	2
Cardiac Arrest	2	2
Obstruction/Occlusion	2	2
Necrosis	2	2
Arthralgia	2	2
Hypovolemic Shock	2	2
Reaction to Medicinal Component of Device	1	1
Pelvic Inflammatory Disease	1	1
Intermenstrual Bleeding	1	1
Implant Pain	1	1
Abdominal Distention	1	1
Perforation	1	1
Exposure to Body Fluids	1	1
Micturition Urgency	1	1
Urinary Retention	1	1
Vomiting	1	1
Muscle Weakness	1	1
Hematoma	1	1
Pain	1	1
Prolapse	1	1
Fluid Discharge	1	1
Genital Bleeding	1	1
No Code Available	1	1