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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
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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