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 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Break 112 112
Difficult to Remove 33 33
Fracture 26 26
Detachment Of Device Component 24 24
Detachment of Device or Device Component 24 24
Adverse Event Without Identified Device or Use Problem 19 19
Calcified 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 Dislodged or Dislocated 8 8
Device Damaged Prior to Use 8 8
Migration or Expulsion of Device 7 7
Occlusion Within Device 7 7
Deformation Due to Compressive Stress 6 6
Device-Device Incompatibility 5 5
Device Contamination with Chemical or Other Material 5 5
Material Deformation 5 5
Device Operates Differently Than Expected 4 4
Difficult to Advance 4 4
Unsealed Device Packaging 4 4
Obstruction of Flow 4 4
Leak/Splash 3 3
Device Contaminated During Manufacture or Shipping 3 3
Packaging Problem 3 3
Material Twisted/Bent 3 3
Use of Device Problem 3 3
Partial Blockage 2 2
Defective Component 2 2
Torn Material 2 2
Material Split, Cut or Torn 2 2
Material Discolored 1 1
Shelf Life Exceeded 1 1
Material Perforation 1 1
Difficult to Insert 1 1
Air Leak 1 1
Contamination 1 1
Material Integrity Problem 1 1
Sticking 1 1
Insufficient Information 1 1
Kinked 1 1
Collapse 1 1
Device Markings/Labelling Problem 1 1
Peeled/Delaminated 1 1
Device Or Device Fragments Location Unknown 1 1
Crack 1 1
Improper or Incorrect Procedure or Method 1 1
Disconnection 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 39 39
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 7 7
Abscess 5 5
Fever 5 5
Inflammation 4 4
Sepsis 4 4
Death 4 4
Obstruction/Occlusion 3 3
No Code Available 3 3
Fistula 3 3
Hematuria 2 2
Bowel Perforation 2 2
Blood Loss 2 2
Peritonitis 2 2
Pleural Effusion 2 2
Pneumothorax 2 2
Myocardial Infarction 2 2
Urinary Tract Infection 2 2
No Information 1 1
Hematoma 1 1
Pyrosis/Heartburn 1 1
Multiple Organ Failure 1 1
Rash 1 1
Injury 1 1
Nausea 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Insufficient Information 1 1
Hemostasis 1 1
Unspecified Kidney or Urinary Problem 1 1
Anxiety 1 1
Patient Problem/Medical Problem 1 1
Weight Changes 1 1
Irritability 1 1
Fibrosis 1 1
Internal Organ Perforation 1 1
Impaired Healing 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Sep-13-2024
2 Boston Scientific Corporation II May-21-2009
-
-