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TPLC
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show TPLC since
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Device
tube, drainage, suprapubic
Product Code
FFA
Regulation Number
876.5090
Device Class
2
MDR Year
MDR Reports
MDR Events
2014
48
48
2015
78
78
2016
51
51
2017
29
29
2018
35
35
2019
26
26
2020
14
14
2021
24
24
2022
17
17
2023
12
12
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
109
109
Difficult to Remove
33
33
Fracture
26
26
Detachment Of Device Component
24
24
Detachment of Device or Device Component
24
24
Calcified
16
16
Adverse Event Without Identified Device or Use Problem
16
16
Material Separation
13
13
Entrapment of Device
12
12
Device Packaging Compromised
12
12
Tear, Rip or Hole in Device Packaging
11
11
Defective Device
11
11
Device Damaged Prior to Use
8
8
Device Dislodged or Dislocated
8
8
Migration or Expulsion of Device
7
7
Occlusion Within Device
7
7
Deformation Due to Compressive Stress
6
6
Device Contamination with Chemical or Other Material
5
5
Device-Device Incompatibility
5
5
Material Deformation
5
5
Device Operates Differently Than Expected
4
4
Difficult to Advance
4
4
Obstruction of Flow
4
4
Unsealed Device Packaging
4
4
Leak/Splash
3
3
Use of Device Problem
3
3
Device Contaminated During Manufacture or Shipping
3
3
Packaging Problem
3
3
Torn Material
2
2
Material Split, Cut or Torn
2
2
Defective Component
2
2
Partial Blockage
2
2
Air Leak
1
1
Collapse
1
1
Component Falling
1
1
Contamination
1
1
Crack
1
1
Material Discolored
1
1
Disconnection
1
1
Peeled/Delaminated
1
1
Fluid/Blood Leak
1
1
Hole In Material
1
1
Kinked
1
1
Improper or Incorrect Procedure or Method
1
1
Material Perforation
1
1
Shelf Life Exceeded
1
1
Sticking
1
1
Device Markings/Labelling Problem
1
1
Device Or Device Fragments Location Unknown
1
1
Material Integrity Problem
1
1
Material Twisted/Bent
1
1
Insufficient Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
144
144
No Patient Involvement
49
49
No Clinical Signs, Symptoms or Conditions
33
33
No Known Impact Or Consequence To Patient
30
30
Unspecified Infection
20
20
Pain
19
19
Device Embedded In Tissue or Plaque
18
18
Hemorrhage/Bleeding
12
12
Foreign Body In Patient
6
6
Abscess
5
5
Fever
5
5
Death
4
4
Inflammation
4
4
Sepsis
4
4
Obstruction/Occlusion
3
3
Fistula
3
3
No Code Available
3
3
Myocardial Infarction
2
2
Pleural Effusion
2
2
Pneumothorax
2
2
Hematuria
2
2
Blood Loss
2
2
Urinary Tract Infection
2
2
Bowel Perforation
2
2
Peritonitis
2
2
Anxiety
1
1
Discomfort
1
1
Complaint, Ill-Defined
1
1
Injury
1
1
Impaired Healing
1
1
Irritability
1
1
Weight Changes
1
1
Rash
1
1
Nausea
1
1
Internal Organ Perforation
1
1
Pyrosis/Heartburn
1
1
Hematoma
1
1
Hemostasis
1
1
Multiple Organ Failure
1
1
Unspecified Kidney or Urinary Problem
1
1
Insufficient Information
1
1
Fibrosis
1
1
No Information
1
1
Patient Problem/Medical Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Corporation
II
May-21-2009
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