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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
151
151
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
400
400
Fluid/Blood Leak
285
285
Material Rupture
69
69
Inflation Problem
49
49
Leak/Splash
46
46
Material Puncture/Hole
24
24
Detachment of Device or Device Component
24
24
Break
19
19
Deflation Problem
16
16
Improper or Incorrect Procedure or Method
11
11
Suction Failure
9
9
Device Dislodged or Dislocated
8
8
Suction Problem
8
8
Material Integrity Problem
8
8
Component Missing
8
8
Fracture
7
7
Obstruction of Flow
6
6
Defective Component
5
5
Expulsion
5
5
Use of Device Problem
5
5
Positioning Failure
4
4
Decrease in Suction
4
4
Material Split, Cut or Torn
4
4
Therapeutic or Diagnostic Output Failure
4
4
Defective Device
4
4
Appropriate Term/Code Not Available
4
4
Migration or Expulsion of Device
4
4
Compatibility Problem
3
3
Component or Accessory Incompatibility
3
3
Loss of or Failure to Bond
3
3
Loose or Intermittent Connection
3
3
Device Damaged Prior to Use
3
3
Infusion or Flow Problem
3
3
Material Separation
3
3
Component Incompatible
3
3
Unintended Deflation
3
3
Mechanical Problem
3
3
Contamination /Decontamination Problem
2
2
Blocked Connection
2
2
Migration
2
2
Insufficient Information
2
2
Partial Blockage
2
2
Off-Label Use
2
2
Positioning Problem
2
2
Crack
2
2
Device Contaminated During Manufacture or Shipping
2
2
No Flow
2
2
Failure to Deflate
2
2
Difficult or Delayed Positioning
2
2
Material Deformation
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
347
347
Hemorrhage/Bleeding
227
227
Insufficient Information
182
182
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
Disseminated Intravascular Coagulation (DIC)
20
20
Blood Loss
19
19
Uterine Perforation
16
16
Laceration(s)
14
14
Foreign Body In Patient
9
9
Low Blood Pressure/ Hypotension
8
8
No Code Available
8
8
No Patient Involvement
8
8
No Information
7
7
Fever
7
7
Hypovolemic Shock
6
6
Thrombosis/Thrombus
6
6
Coagulation Disorder
4
4
Distress
2
2
Bacterial Infection
2
2
Swelling/ Edema
2
2
Cough
2
2
Tachycardia
2
2
Shock
2
2
Abscess
2
2
Pain
2
2
Rupture
2
2
Necrosis
2
2
Wound Dehiscence
2
2
Abdominal Pain
2
2
Pelvic Inflammatory Disease
1
1
Multiple Organ Failure
1
1
Intermenstrual Bleeding
1
1
Exposure to Body Fluids
1
1
Micturition Urgency
1
1
Urinary Retention
1
1
Vomiting
1
1
Discomfort
1
1
Implant Pain
1
1
Perforation
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
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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