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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
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 2
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
SINAPI BIOMEDICAL (PTY) LTD.
  SUBSTANTIALLY EQUIVALENT 1
UJENZI CHARITABLE TRUST
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 90 90
2020 90 90
2021 113 113
2022 274 274
2023 228 228
2024 151 151

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 398 398
Fluid/Blood Leak 276 276
Material Rupture 58 58
Inflation Problem 37 37
Detachment of Device or Device Component 23 23
Material Puncture/Hole 23 23
Leak/Splash 20 20
Break 17 17
Improper or Incorrect Procedure or Method 11 11
Deflation Problem 10 10
Suction Failure 9 9
Material Integrity Problem 8 8
Suction Problem 8 8
Device Dislodged or Dislocated 7 7
Fracture 7 7
Component Missing 7 7
Obstruction of Flow 6 6
Expulsion 5 5
Defective Component 5 5
Use of Device Problem 4 4
Positioning Failure 4 4
Therapeutic or Diagnostic Output Failure 4 4
Decrease in Suction 4 4
Defective Device 4 4
Material Split, Cut or Torn 4 4
Migration or Expulsion of Device 4 4
Material Separation 3 3
Unintended Deflation 3 3
Mechanical Problem 3 3
Component or Accessory Incompatibility 3 3
Loose or Intermittent Connection 3 3
Compatibility Problem 3 3
Component Incompatible 3 3
Appropriate Term/Code Not Available 3 3
Infusion or Flow Problem 3 3
Failure to Deflate 2 2
No Flow 2 2
Contamination /Decontamination Problem 2 2
Difficult or Delayed Positioning 2 2
Device Damaged Prior to Use 2 2
Insufficient Information 2 2
Positioning Problem 2 2
Material Deformation 2 2
Migration 2 2
Device Contaminated During Manufacture or Shipping 2 2
Unexpected Therapeutic Results 1 1
Disconnection 1 1
Output Problem 1 1
Difficult to Remove 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 347 347
Hemorrhage/Bleeding 216 216
Insufficient Information 182 182
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 118 118
No Consequences Or Impact To Patient 112 112
No Known Impact Or Consequence To Patient 31 31
Disseminated Intravascular Coagulation (DIC) 20 20
Uterine Perforation 15 15
Laceration(s) 14 14
Blood Loss 11 11
Low Blood Pressure/ Hypotension 8 8
Foreign Body In Patient 7 7
No Code Available 6 6
Thrombosis/Thrombus 6 6
Fever 6 6
No Information 4 4
Coagulation Disorder 4 4
Hypovolemic Shock 3 3
Distress 2 2
Bacterial Infection 2 2
Swelling/ Edema 2 2
Cough 2 2
Tachycardia 2 2
Shock 2 2
Abscess 2 2
No Patient Involvement 2 2
Rupture 2 2
Necrosis 2 2
Wound Dehiscence 2 2
Pelvic Inflammatory Disease 1 1
Intermenstrual Bleeding 1 1
Exposure to Body Fluids 1 1
Micturition Urgency 1 1
Urinary Retention 1 1
Vomiting 1 1
Implant Pain 1 1
Perforation 1 1
Pain 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
Menstrual Irregularities 1 1
Cervical Changes 1 1
Damage to Ligament(s) 1 1

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