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U.S. Department of Health and Human Services

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 CodeOQY
Regulation Number 884.4530
Device Class 2


Premarket Reviews
ManufacturerDecision
ALYDIA HEALTH
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
SINAPI BIOMEDICAL (PTY) , LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 113 113
2022 274 274
2023 228 228
2024 215 215
2025 180 180
2026 17 17

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

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