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 cushion, flotation
Regulation Description Flotation cushion.
Product CodeKIC
Regulation Number 890.3175
Device Class 1

MDR Year MDR Reports MDR Events
2020 4 4
2021 12 12
2022 6 6
2023 12 12
2024 14 14
2025 8 8
2026 6 8

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 20 20
Use of Device Problem 9 9
Material Split, Cut or Torn 4 4
Material Integrity Problem 4 4
Material Puncture/Hole 3 3
Improper or Incorrect Procedure or Method 3 3
Device Difficult to Maintain 2 2
Material Perforation 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Slipped 1 1
Mechanical Problem 1 1
Patient-Device Incompatibility 1 1
Defective Device 1 1
Deflation Problem 1 1
Patient Device Interaction Problem 1 1
Gas/Air Leak 1 1
Material Deformation 1 1
Explosion 1 1
Naturally Worn 1 1
Material Too Soft/Flexible 1 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pressure Sores 44 44
No Clinical Signs, Symptoms or Conditions 8 10
Insufficient Information 6 6
Tissue Breakdown 4 4
Skin Erosion 2 2
Unspecified Infection 1 1
Cellulitis 1 1
Laceration(s) 1 1

-
-