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TPLC
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Device
catheter, retention type, balloon
Product Code
EZL
Regulation Number
876.5130
Device Class
2
Premarket Reviews
Manufacturer
Decision
AMSINO INTERNATIONAL, INC.
SUBSTANTIALLY EQUIVALENT
1
APOLLON CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
BIOSENSORS INTERNATIONAL PTE LTD
SUBSTANTIALLY EQUIVALENT
1
C. R. BARD, INC.
SUBSTANTIALLY EQUIVALENT
1
CHANGZHOU RONGXIN MEDICINE MINIMAL INVASION TECHNOLOGY
SUBSTANTIALLY EQUIVALENT
1
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
EMMY MEDICAL, LLC.
SUBSTANTIALLY EQUIVALENT
1
FLUME CATHETER COMPANY, LTD.
SUBSTANTIALLY EQUIVALENT
1
HANGZHOU PRIMECARE MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
HR PHARMACEUTICALS, INC.
SUBSTANTIALLY EQUIVALENT
1
JIANGXI YIKANG MEDICAL INSTRUMENT GROUP CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
NELLIE MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
PATHWAY, LLC
SUBSTANTIALLY EQUIVALENT
2
POIESIS MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
POTRERO MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT - KIT
1
SAFE MEDICAL DESIGN
SUBSTANTIALLY EQUIVALENT
1
SILQ TECHNOLOGIES CORPORATION
SUBSTANTIALLY EQUIVALENT
1
SILQ TECHNOLOGIES, CORP.
SUBSTANTIALLY EQUIVALENT
1
TELEFLEX MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
THE FLUME CATHETER COMPANY, LTD.
SUBSTANTIALLY EQUIVALENT
1
URETHROTECH
SUBSTANTIALLY EQUIVALENT
1
WELL LEAD MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
677
677
2019
670
670
2020
711
711
2021
701
701
2022
885
885
2023
507
507
Device Problems
MDRs with this Device Problem
Events in those MDRs
Burst Container or Vessel
556
556
Deflation Problem
539
539
Fluid/Blood Leak
536
536
Material Puncture/Hole
254
254
Difficult to Remove
253
253
Break
253
253
Leak/Splash
225
225
Decrease in Pressure
209
209
Material Invagination
180
180
Material Rupture
152
152
Material Split, Cut or Torn
131
131
Inflation Problem
123
123
Partial Blockage
122
122
Adverse Event Without Identified Device or Use Problem
119
119
Erratic or Intermittent Display
107
107
Failure to Infuse
97
97
Device Dislodged or Dislocated
90
90
Device Fell
74
74
Inaccurate Flow Rate
71
71
Component Missing
70
70
Material Fragmentation
65
65
Detachment of Device or Device Component
59
59
Material Deformation
58
58
Device Slipped
51
51
Obstruction of Flow
46
46
Material Integrity Problem
42
42
Patient-Device Incompatibility
40
40
Device Contamination with Chemical or Other Material
39
39
No Flow
39
39
Patient Device Interaction Problem
36
36
Component Misassembled
35
35
Incorrect Measurement
34
34
Physical Resistance/Sticking
33
33
Material Twisted/Bent
31
31
Difficult to Insert
30
30
Material Protrusion/Extrusion
29
29
Failure to Deflate
28
28
Tear, Rip or Hole in Device Packaging
27
27
Unintended Deflation
25
25
Insufficient Information
25
25
Dent in Material
24
24
Fracture
24
24
Hole In Material
23
23
Device Damaged Prior to Use
23
23
Mushroomed
22
22
Biocompatibility
21
21
Temperature Problem
20
20
Deformation Due to Compressive Stress
19
19
Calcified
18
18
Component Falling
18
18
No Display/Image
17
17
Material Perforation
17
17
Complete Blockage
16
16
Misassembled
15
15
Inadequate Instructions for Healthcare Professional
14
14
Short Fill
14
14
Incorrect, Inadequate or Imprecise Result or Readings
14
14
Difficult to Advance
14
14
Infusion or Flow Problem
13
13
Gas/Air Leak
13
13
Defective Device
13
13
Crack
13
13
Restricted Flow rate
13
13
Detachment Of Device Component
12
12
Material Discolored
12
12
Low Readings
12
12
Device Operates Differently Than Expected
12
12
Sharp Edges
12
12
Appropriate Term/Code Not Available
11
11
Use of Device Problem
10
10
Off-Label Use
10
10
Inadequacy of Device Shape and/or Size
9
9
Disconnection
9
9
Therapeutic or Diagnostic Output Failure
9
9
Scratched Material
9
9
Gel Leak
8
8
Product Quality Problem
8
8
Nonstandard Device
8
8
Fitting Problem
8
8
High Readings
8
8
Contamination /Decontamination Problem
8
8
Device Markings/Labelling Problem
7
7
Manufacturing, Packaging or Shipping Problem
7
7
Improper or Incorrect Procedure or Method
7
7
Material Too Rigid or Stiff
7
7
Contamination
7
7
Material Separation
6
6
Defective Component
6
6
Device Displays Incorrect Message
6
6
Split
6
6
Failure to Advance
6
6
Improper Flow or Infusion
6
6
Output Problem
6
6
Blocked Connection
6
6
Missing Information
6
6
Device Sensing Problem
5
5
Inability to Irrigate
5
5
Collapse
4
4
Filling Problem
4
4
Device Contaminated During Manufacture or Shipping
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1727
1727
No Consequences Or Impact To Patient
1232
1232
No Known Impact Or Consequence To Patient
1045
1045
Pain
248
248
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
154
154
No Patient Involvement
151
151
Insufficient Information
133
133
Urinary Tract Infection
108
108
No Information
99
99
Patient Problem/Medical Problem
72
72
Discomfort
66
66
Hemorrhage/Bleeding
64
64
Hematuria
58
58
Foreign Body In Patient
57
57
No Code Available
42
42
Urinary Retention
39
39
Blood Loss
27
27
Unspecified Infection
23
23
Injury
13
13
Genital Bleeding
12
12
Skin Inflammation/ Irritation
12
12
Device Embedded In Tissue or Plaque
9
9
Tissue Damage
9
9
Burning Sensation
9
9
Inflammation
7
7
Sepsis
7
7
Fever
7
7
Perforation
6
6
Skin Tears
6
6
Tissue Breakdown
6
6
Urinary Incontinence
6
6
Unspecified Tissue Injury
5
5
Irritation
5
5
Incontinence
5
5
Death
4
4
Local Reaction
4
4
Abdominal Cramps
4
4
Cancer
3
3
Thrombus
3
3
Sweating
3
3
Cellulitis
3
3
Abrasion
3
3
Bacterial Infection
3
3
Laceration(s)
3
3
Muscle Spasm(s)
3
3
Skin Discoloration
3
3
Internal Organ Perforation
2
2
Rash
2
2
Erosion
2
2
Fistula
2
2
High Blood Pressure/ Hypertension
2
2
Diaphoresis
2
2
Fungal Infection
2
2
Dizziness
2
2
Anxiety
2
2
Distress
2
2
Unspecified Gastrointestinal Problem
2
2
Unspecified Kidney or Urinary Problem
2
2
Alteration In Body Temperature
2
2
Dysuria
2
2
Swelling/ Edema
2
2
Alteration in Body Temperature
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Localized Skin Lesion
1
1
Not Applicable
1
1
Test Result
1
1
Discharge
1
1
Viral Infection
1
1
Urinary Frequency
1
1
Vomiting
1
1
Respiratory Distress
1
1
Scar Tissue
1
1
Ulceration
1
1
Irritability
1
1
Toxicity
1
1
Sedation
1
1
Impaired Healing
1
1
Inadequate Pain Relief
1
1
Reaction
1
1
Needle Stick/Puncture
1
1
Respiratory Failure
1
1
Shaking/Tremors
1
1
Sleep Dysfunction
1
1
Burn, Thermal
1
1
Chemical Exposure
1
1
Low Blood Pressure/ Hypotension
1
1
Hypoxia
1
1
Failure of Implant
1
1
Headache
1
1
Hematoma
1
1
Abscess
1
1
Anemia
1
1
Stroke/CVA
1
1
Edema
1
1
Fatigue
1
1
Pulmonary Dysfunction
1
1
Skin Irritation
1
1
Tachycardia
1
1
Nausea
1
1
Abdominal Pain
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
C.R. Bard Inc
II
Sep-23-2021
2
Degania Medical Devices Pvt. Ltd.
II
Apr-23-2020
3
Degania Silicone, Ltd.
II
Jan-13-2020
4
Degania Silicone, Ltd.
II
Sep-20-2018
5
Medline Industries Inc
II
May-18-2020
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