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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
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
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
Defective Device
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
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
Off-Label Use
2
2
Blocked Connection
2
2
Contamination /Decontamination Problem
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
Component or Accessory Incompatibility
1
1
Fitting Problem
1
1
Difficult to Remove
1
1
Mechanical Problem
1
1
Device Slipped
1
1
Unexpected Therapeutic Results
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
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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