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 bag, intestine
Product CodeKGY
Regulation Number 878.4100
Device Class 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 14 14
2021 14 14
2022 20 20
2023 17 17
2024 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 34 34
Break 24 24
Device Contaminated During Manufacture or Shipping 5 5
Material Separation 4 4
Material Protrusion/Extrusion 4 4
Material Rupture 3 3
Burst Container or Vessel 2 2
Material Puncture/Hole 2 2
Material Fragmentation 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Fell 1 1
Material Integrity Problem 1 1
Unraveled Material 1 1
Component Missing 1 1
Obstruction of Flow 1 1
Tear, Rip or Hole in Device Packaging 1 1
Detachment of Device or Device Component 1 1
Fluid/Blood Leak 1 1
Extra Components 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 60 60
Insufficient Information 13 13
No Consequences Or Impact To Patient 11 11
Foreign Body In Patient 2 2
No Patient Involvement 2 2
Intraoperative Pain 1 1
Exposure to Body Fluids 1 1
Nerve Damage 1 1
Laceration(s) 1 1
Capsular Contracture 1 1

-
-