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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
CLINICAL INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 2
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
GLENVEIGH SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SINAPI BIOMEDICAL (PTY) LTD.
  SUBSTANTIALLY EQUIVALENT 1
UJENZI CHARITABLE TRUST
  SUBSTANTIALLY EQUIVALENT 1
UTAH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 5 5
2016 9 9
2017 3 3
2018 55 55
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 352 352
Fluid/Blood Leak 248 248
Material Rupture 61 61
Inflation Problem 48 48
Leak/Splash 45 45
Detachment of Device or Device Component 23 23
Material Puncture/Hole 21 21
Deflation Problem 16 16
Break 15 15
Improper or Incorrect Procedure or Method 11 11
Suction Failure 9 9
Device Dislodged or Dislocated 8 8
Suction Problem 8 8
Component Missing 8 8
Obstruction of Flow 6 6
Use of Device Problem 5 5
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
Therapeutic or Diagnostic Output Failure 4 4
Material Split, Cut or Torn 4 4
Appropriate Term/Code Not Available 4 4
Loss of or Failure to Bond 3 3
Infusion or Flow Problem 3 3
Fracture 3 3
Device Damaged Prior to Use 3 3
Loose or Intermittent Connection 3 3
Material Separation 3 3
Off-Label Use 2 2
Partial Blockage 2 2
Device Contaminated During Manufacture or Shipping 2 2
Material Deformation 2 2
Positioning Problem 2 2
Insufficient Information 2 2
Failure to Deflate 2 2
Crack 2 2
Blocked Connection 2 2
Unintended Deflation 2 2
No Flow 2 2
Difficult or Delayed Positioning 2 2
Contamination /Decontamination Problem 2 2
Burst Container or Vessel 1 1
Difficult to Remove 1 1
Material Twisted/Bent 1 1
Device Operates Differently Than Expected 1 1
Compatibility Problem 1 1
Migration 1 1
Unexpected Therapeutic Results 1 1
Output Problem 1 1
Mechanical Problem 1 1
Device Slipped 1 1
Separation Problem 1 1
Disconnection 1 1
Difficult to Insert 1 1
Fitting Problem 1 1
Hole In Material 1 1
Complete Blockage 1 1
Component Incompatible 1 1
Component or Accessory Incompatibility 1 1
Installation-Related Problem 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 272 272
Hemorrhage/Bleeding 189 189
Insufficient Information 147 147
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
Blood Loss 19 19
Disseminated Intravascular Coagulation (DIC) 18 18
Laceration(s) 13 13
Uterine Perforation 13 13
No Code Available 8 8
No Patient Involvement 8 8
Foreign Body In Patient 8 8
No Information 7 7
Low Blood Pressure/ Hypotension 7 7
Fever 7 7
Hypovolemic Shock 6 6
Thrombosis/Thrombus 6 6
Coagulation Disorder 4 4
Cough 2 2
Swelling/ Edema 2 2
Abdominal Pain 2 2
Abscess 2 2
Bacterial Infection 2 2
Rupture 2 2
Distress 2 2
Pain 2 2
Necrosis 2 2
Tachycardia 2 2
Urinary Retention 1 1
Internal Organ Perforation 1 1
Pelvic Inflammatory Disease 1 1
Perforation 1 1
Pulmonary Edema 1 1
Sepsis 1 1
Shock 1 1
Discomfort 1 1
Bronchospasm 1 1
Anxiety 1 1
Vomiting 1 1
Exposure to Body Fluids 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
Implant Pain 1 1
Intermenstrual Bleeding 1 1
Fluid Discharge 1 1
Multiple Organ Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Clinical Innovations, LLC II Oct-15-2015
2 Clinical Innovations, LLC II Jan-27-2015
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