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TPLC
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Device
intrauterine tamponade balloon
Definition
provides temporary control or reduction of postpartum uterine bleeding
Product Code
OQY
Regulation Number
884.4530
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
31
31
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
342
342
Fluid/Blood Leak
242
242
Material Rupture
59
59
Inflation Problem
47
47
Leak/Splash
45
45
Detachment of Device or Device Component
22
22
Material Puncture/Hole
19
19
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
Expulsion
5
5
Use of Device Problem
5
5
Defective Component
5
5
Material Integrity Problem
4
4
Material Split, Cut or Torn
4
4
Therapeutic or Diagnostic Output Failure
4
4
Appropriate Term/Code Not Available
4
4
Migration or Expulsion of Device
4
4
Decrease in Suction
4
4
Positioning Failure
4
4
Fracture
3
3
Loss of or Failure to Bond
3
3
Loose or Intermittent Connection
3
3
Material Separation
3
3
Defective Device
3
3
Device Damaged Prior to Use
3
3
Infusion or Flow Problem
3
3
Device Contaminated During Manufacture or Shipping
2
2
Material Deformation
2
2
No Flow
2
2
Insufficient Information
2
2
Positioning Problem
2
2
Failure to Deflate
2
2
Unintended Deflation
2
2
Blocked Connection
2
2
Contamination /Decontamination Problem
2
2
Off-Label Use
2
2
Partial Blockage
2
2
Crack
2
2
Difficult or Delayed Positioning
2
2
Disconnection
1
1
Hole In Material
1
1
Difficult to Insert
1
1
Burst Container or Vessel
1
1
Complete Blockage
1
1
Component Incompatible
1
1
Mechanical Problem
1
1
Device Slipped
1
1
Unexpected Therapeutic Results
1
1
Component or Accessory Incompatibility
1
1
Fitting Problem
1
1
Difficult to Remove
1
1
Separation Problem
1
1
Patient Device Interaction Problem
1
1
Migration
1
1
Output Problem
1
1
Material Twisted/Bent
1
1
Installation-Related Problem
1
1
Compatibility Problem
1
1
Device Operates Differently Than Expected
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
258
258
Hemorrhage/Bleeding
180
180
Insufficient Information
141
141
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
Foreign Body In Patient
8
8
No Code Available
8
8
No Patient Involvement
8
8
Fever
7
7
Low Blood Pressure/ Hypotension
7
7
No Information
7
7
Hypovolemic Shock
6
6
Thrombosis/Thrombus
6
6
Coagulation Disorder
4
4
Pain
2
2
Rupture
2
2
Abscess
2
2
Necrosis
2
2
Swelling/ Edema
2
2
Bacterial Infection
2
2
Abdominal Pain
2
2
Cough
2
2
Tachycardia
2
2
Exposure to Body Fluids
1
1
Muscle Weakness
1
1
Sepsis
1
1
Shock
1
1
Internal Organ Perforation
1
1
Implant Pain
1
1
Urinary Retention
1
1
Pelvic Inflammatory Disease
1
1
Multiple Organ Failure
1
1
Damage to Ligament(s)
1
1
Pulmonary Edema
1
1
Micturition Urgency
1
1
Hematoma
1
1
Hypersensitivity/Allergic reaction
1
1
Fluid Discharge
1
1
Perforation
1
1
Bronchospasm
1
1
Distress
1
1
Discomfort
1
1
Miscarriage
1
1
Vomiting
1
1
Intermenstrual Bleeding
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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