Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device tube, drainage, suprapubic
Product CodeFFA
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
-
-