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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 52 52

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 350 350
Fluid/Blood Leak 239 239
Material Rupture 50 50
Inflation Problem 36 36
Detachment of Device or Device Component 22 22
Material Puncture/Hole 20 20
Leak/Splash 19 19
Break 13 13
Improper or Incorrect Procedure or Method 11 11
Deflation Problem 10 10
Suction Failure 9 9
Suction Problem 8 8
Device Dislodged or Dislocated 7 7
Component Missing 7 7
Obstruction of Flow 6 6
Defective Component 5 5
Expulsion 5 5
Positioning Failure 4 4
Defective Device 4 4
Decrease in Suction 4 4
Material Integrity Problem 4 4
Migration or Expulsion of Device 4 4
Material Split, Cut or Torn 4 4
Therapeutic or Diagnostic Output Failure 4 4
Use of Device Problem 4 4
Appropriate Term/Code Not Available 3 3
Infusion or Flow Problem 3 3
Fracture 3 3
Loose or Intermittent Connection 3 3
Material Separation 3 3
Device Contaminated During Manufacture or Shipping 2 2
Material Deformation 2 2
Device Damaged Prior to Use 2 2
Positioning Problem 2 2
Insufficient Information 2 2
Failure to Deflate 2 2
No Flow 2 2
Unintended Deflation 2 2
Difficult or Delayed Positioning 2 2
Contamination /Decontamination Problem 2 2
Loss of or Failure to Bond 1 1
Material Twisted/Bent 1 1
Difficult to Remove 1 1
Compatibility Problem 1 1
Migration 1 1
Unexpected Therapeutic Results 1 1
Device Slipped 1 1
Mechanical Problem 1 1
Crack 1 1
Blocked Connection 1 1
Output Problem 1 1
Disconnection 1 1
Difficult to Insert 1 1
Partial Blockage 1 1
Fitting Problem 1 1
Complete Blockage 1 1
Component Incompatible 1 1
Component or Accessory Incompatibility 1 1
Patient Device Interaction Problem 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 272 272
Hemorrhage/Bleeding 178 178
Insufficient Information 147 147
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) 18 18
Laceration(s) 13 13
Uterine Perforation 12 12
Blood Loss 11 11
Low Blood Pressure/ Hypotension 7 7
Fever 6 6
Foreign Body In Patient 6 6
No Code Available 6 6
Thrombosis/Thrombus 6 6
No Information 4 4
Coagulation Disorder 4 4
Hypovolemic Shock 3 3
Abscess 2 2
Bacterial Infection 2 2
Rupture 2 2
Tachycardia 2 2
Necrosis 2 2
Swelling/ Edema 2 2
Cough 2 2
Distress 2 2
No Patient Involvement 2 2
Intermenstrual Bleeding 1 1
Fluid Discharge 1 1
Implant Pain 1 1
Internal Organ Perforation 1 1
Pain 1 1
Pelvic Inflammatory Disease 1 1
Perforation 1 1
Pulmonary Edema 1 1
Sepsis 1 1
Shock 1 1
Urinary Retention 1 1
Vomiting 1 1
Anxiety 1 1
Bronchospasm 1 1
Exposure to Body Fluids 1 1
Abdominal Pain 1 1
Micturition Urgency 1 1
Hematoma 1 1
Hypersensitivity/Allergic reaction 1 1
Damage to Ligament(s) 1 1
Miscarriage 1 1
Muscle Weakness 1 1

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