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
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 23 23
Detachment of Device or Device Component 16 16
Difficult to Remove 14 14
Material Separation 11 11
Defective Device 11 11
Adverse Event Without Identified Device or Use Problem 8 8
Device Dislodged or Dislocated 6 6
Deformation Due to Compressive Stress 6 6
Device-Device Incompatibility 5 5
Material Deformation 5 5
Difficult to Advance 4 4
Obstruction of Flow 4 4
Entrapment of Device 4 4
Device Contaminated During Manufacture or Shipping 3 3
Material Split, Cut or Torn 2 2
Use of Device Problem 2 2
Unsealed Device Packaging 2 2
Device Markings/Labelling Problem 1 1
Defective Component 1 1
Tear, Rip or Hole in Device Packaging 1 1
Fracture 1 1
Collapse 1 1
Contamination 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 33 33
No Consequences Or Impact To Patient 15 15
No Known Impact Or Consequence To Patient 12 12
Pain 7 7
Hemorrhage/Bleeding 7 7
Foreign Body In Patient 5 5
No Patient Involvement 4 4
Device Embedded In Tissue or Plaque 4 4
Fever 3 3
Abscess 2 2
Death 2 2
Unspecified Infection 2 2
Sepsis 2 2
No Code Available 2 2
Unspecified Kidney or Urinary Problem 1 1
Insufficient Information 1 1
Urinary Tract Infection 1 1
Rash 1 1
Anxiety 1 1
Complaint, Ill-Defined 1 1
Obstruction/Occlusion 1 1
Hematuria 1 1
Inflammation 1 1
Internal Organ Perforation 1 1
Hemostasis 1 1
Fistula 1 1
Pyrosis/Heartburn 1 1

-
-