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 set, anesthesia, paracervical
Product CodeHEE
Regulation Number 884.5100
Device Class 2

MDR Year MDR Reports MDR Events
2016 1 1
2017 5 5
2018 1 1
2019 3 3
2021 1 1
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4 4
Leak/Splash 2 2
Component Missing 2 2
Detachment of Device or Device Component 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Unintended Movement 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Misassembled 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4 4
Insufficient Information 4 4
No Clinical Signs, Symptoms or Conditions 2 2
No Consequences Or Impact To Patient 2 2
Foreign Body In Patient 2 2
Emotional Changes 1 1
Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CooperSurgical, Inc. III Oct-06-2015
-
-