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TPLC
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Device
device, hemostasis, vascular
Product Code
MGB
Device Class
3
Premarket Approvals (PMA)
2018
2019
2020
2021
2022
2023
23
27
10
17
11
2
MDR Year
MDR Reports
MDR Events
2018
5679
5679
2019
6156
6156
2020
5927
5927
2021
7586
7586
2022
9457
9466
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Cycle
13084
13084
Material Separation
3887
3887
Improper or Incorrect Procedure or Method
1977
1977
Malposition of Device
1958
1958
Adverse Event Without Identified Device or Use Problem
1536
1536
Device Operates Differently Than Expected
1196
1196
Patient Device Interaction Problem
1079
1079
Difficult to Remove
973
973
Insufficient Information
971
971
Activation, Positioning or Separation Problem
960
960
Entrapment of Device
951
951
Detachment of Device or Device Component
901
901
Difficult to Insert
890
890
Off-Label Use
860
860
Difficult to Open or Close
757
757
Obstruction of Flow
734
734
Positioning Failure
696
696
Activation Failure
612
612
Material Deformation
599
599
Physical Resistance/Sticking
572
572
Mechanical Jam
534
534
Break
531
531
Detachment Of Device Component
455
455
Failure to Advance
455
455
Decrease in Pressure
434
434
Retraction Problem
374
374
Material Rupture
358
358
Failure to Fire
352
352
Difficult to Advance
300
300
Product Quality Problem
290
290
Deformation Due to Compressive Stress
258
258
Misconnection
221
221
Unintended System Motion
165
165
Material Split, Cut or Torn
157
157
Component Missing
143
143
Appropriate Term/Code Not Available
141
150
Difficult or Delayed Activation
124
124
Premature Activation
118
118
Firing Problem
116
116
Failure to Cut
115
115
Difficult or Delayed Positioning
112
112
Positioning Problem
103
103
Material Twisted/Bent
97
97
Therapy Delivered to Incorrect Body Area
95
95
Inadequate or Insufficient Training
94
94
Activation Problem
94
94
Device Damaged by Another Device
88
88
Unintended Movement
84
84
Migration
83
92
Burst Container or Vessel
80
80
Separation Failure
78
78
Partial Blockage
73
73
Migration or Expulsion of Device
72
72
Noise, Audible
71
71
Use of Device Problem
67
76
Deflation Problem
61
61
Material Puncture/Hole
58
58
Defective Component
57
57
Kinked
53
53
Loosening of Implant Not Related to Bone-Ingrowth
45
45
No Apparent Adverse Event
42
42
Therapeutic or Diagnostic Output Failure
40
40
Component Misassembled
39
39
Material Frayed
37
37
Fracture
35
35
Bent
34
34
Expulsion
33
33
Difficult To Position
32
32
Defective Device
31
31
Leak/Splash
30
30
Crack
29
29
Patient-Device Incompatibility
26
26
Misfire
21
21
Device Dislodged or Dislocated
20
20
Mechanical Problem
20
20
Material Fragmentation
19
19
Accessory Incompatible
19
19
Loose or Intermittent Connection
17
17
Physical Property Issue
15
15
Unsealed Device Packaging
14
14
Stretched
14
14
Separation Problem
13
13
Peeled/Delaminated
11
11
Device Contamination with Chemical or Other Material
11
11
Material Integrity Problem
10
10
Output Problem
9
9
Contamination /Decontamination Problem
8
8
Difficult to Flush
8
8
Failure to Seal
8
8
Image Orientation Incorrect
7
7
Failure to Deliver
7
7
Device Operational Issue
6
6
Pressure Problem
6
6
Torn Material
6
6
Scratched Material
5
5
Device Damaged Prior to Use
5
5
Device Issue
4
4
Physical Resistance
4
4
Failure to Form Staple
4
4
No Flow
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
14927
14936
No Consequences Or Impact To Patient
14134
14134
Blood Loss
937
937
Hematoma
848
857
Hemorrhage/Bleeding
709
709
Insufficient Information
481
481
Obstruction/Occlusion
421
421
Tissue Damage
419
419
Pain
366
366
Pseudoaneurysm
326
335
Occlusion
324
324
Unspecified Tissue Injury
320
320
No Known Impact Or Consequence To Patient
309
309
Foreign Body In Patient
301
301
Extravasation
233
233
No Information
215
215
Vascular Dissection
175
175
No Code Available
134
134
Intimal Dissection
132
132
Stenosis
127
127
Unspecified Infection
122
122
Thrombosis
110
110
Thrombosis/Thrombus
106
106
Low Blood Pressure/ Hypotension
98
98
No Patient Involvement
97
97
Ischemia
90
90
Death
81
81
Swelling/ Edema
76
76
Device Embedded In Tissue or Plaque
67
67
Diminished Pulse Pressure
65
65
Perforation
51
51
Perforation of Vessels
47
47
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
44
53
Failure of Implant
37
37
Retroperitoneal Hemorrhage
36
36
Inflammation
35
35
Swelling
35
35
Numbness
35
35
Fistula
33
33
Embolism
29
29
Anemia
28
28
Embolism/Embolus
26
26
Aneurysm
22
22
Stroke/CVA
21
21
Renal Failure
20
20
Bruise/Contusion
18
18
Calcium Deposits/Calcification
18
18
Shock
17
17
Sepsis
16
16
Claudication
16
16
Vessel Or Plaque, Device Embedded In
16
16
Laceration(s)
15
24
Nerve Damage
14
14
Hypersensitivity/Allergic reaction
14
14
Loss Of Pulse
14
14
Thrombus
14
14
Cardiac Arrest
13
13
Hemostasis
12
12
Myocardial Infarction
12
12
Abscess
11
11
Local Reaction
11
11
Rupture
10
10
Discomfort
10
10
Post Operative Wound Infection
10
10
Fever
10
10
Unspecified Vascular Problem
10
10
Rash
9
9
Ecchymosis
9
9
Prolapse
9
9
Foreign Body Embolism
8
8
Dizziness
7
7
Hypovolemic Shock
7
7
Tachycardia
6
6
Skin Discoloration
6
6
Vascular System (Circulation), Impaired
6
6
Loss of consciousness
6
6
Injury
6
6
Cramp(s) /Muscle Spasm(s)
6
6
Patient Problem/Medical Problem
6
6
Thromboembolism
5
5
Multiple Organ Failure
5
5
Implant Pain
5
5
Skin Infection
5
5
Cardiogenic Shock
5
5
Discharge
5
5
Vasoconstriction
5
5
Chest Pain
5
5
Bacterial Infection
5
5
Bradycardia
5
5
Abdominal Pain
5
5
Arrhythmia
4
4
Cellulitis
4
4
Embolus
4
4
Erythema
4
4
High Blood Pressure/ Hypertension
4
4
Dyspnea
4
4
Fatigue
4
4
Weakness
4
4
Scar Tissue
4
4
Ambulation Difficulties
4
4
Recalls
Manufacturer
Recall Class
Date Posted
1
Terumo Medical Corp
II
Jun-29-2018
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