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 tape, measuring, rulers and calipers
Product CodeFTY
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 11 11
2020 112 112
2021 161 161
2022 93 93
2023 9 9
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Break 327 327
Fracture 22 22
Crack 16 16
Naturally Worn 14 14
Material Twisted/Bent 6 6
Component Missing 5 5
Detachment of Device or Device Component 4 4
Material Fragmentation 4 4
Labelling, Instructions for Use or Training Problem 4 4
Material Separation 3 3
Material Deformation 3 3
Mechanical Jam 2 2
Scratched Material 2 2
Unintended Movement 1 1
No Apparent Adverse Event 1 1
Device Fell 1 1
Mechanics Altered 1 1
Material Integrity Problem 1 1
Device Markings/Labelling Problem 1 1
Difficult to Open or Close 1 1
Solder Joint Fracture 1 1
Defective Device 1 1
Deformation Due to Compressive Stress 1 1
Connection Problem 1 1
Device Damaged Prior to Use 1 1
Corroded 1 1
Misassembled 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 297 297
No Patient Involvement 38 38
No Known Impact Or Consequence To Patient 32 32
No Consequences Or Impact To Patient 24 24
Insufficient Information 6 6
No Information 4 4

-
-