• 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 instrument, manual, specialized obstetric-gynecologic
Regulation Description Obstetric-gynecologic specialized manual instrument.
Product CodeKNA
Regulation Number 884.4530
Device Class 2

MDR Year MDR Reports MDR Events
2017 37 37
2018 62 62
2019 5 5
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 26 26
Material Rupture 17 17
Inflation Problem 13 13
Hole In Material 11 11
Break 8 8
Fluid Leak 7 7
Burst Container or Vessel 6 6
Deflation Problem 5 5
Device Operates Differently Than Expected 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Detachment Of Device Component 4 4
Partial Blockage 3 3
Split 3 3
Component Missing 2 2
Disconnection 2 2
Filling Problem 2 2
Unintended Ejection 1 1
Component Falling 1 1
Material Separation 1 1
Device Slipped 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Material Puncture/Hole 1 1
Blocked Connection 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Torn Material 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Migration 1 1
Device Operational Issue 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 41 41
No Consequences Or Impact To Patient 34 34
Blood Loss 8 8
No Code Available 8 8
No Patient Involvement 6 6
Hemorrhage/Bleeding 6 6
No Information 4 4
No Clinical Signs, Symptoms or Conditions 1 1
Unspecified Infection 1 1
Laceration(s) 1 1
Necrosis 1 1
Perforation 1 1
Scar Tissue 1 1
Abnormal Vaginal Discharge 1 1
Coagulation Disorder 1 1
Death 1 1

-
-