• 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 implant, dermal, for aesthetic use
Product CodeLMH
Device Class 3

Premarket Approvals (PMA)
2015 2016 2017 2018 2019 2020
60 45 52 57 68 5

Device Problems
Adverse Event Without Identified Device or Use Problem 4171
Detachment of Device or device Component 434
Detachment Of Device Component 376
Gel Leak 305
Expulsion 237
Improper or Incorrect Procedure or Method 230
Crack 203
Break 196
Leak / Splash 195
Migration or Expulsion of Device 85
Burst Container or Vessel 73
Off-Label Use 66
Difficult or Delayed Positioning 48
Difficult or Delayed Activation 40
Migration 37
Defective Component 27
Use of Device Problem 22
Insufficient Information 21
Coagulation in Device or device Ingredient 13
Shelf Life Exceeded 11
Device Contamination with Chemical or Other Material 11
Clumping in Device or Device Ingredient 7
Fracture 7
Patient-Device Incompatibility 7
Difficult to Remove 6
Unintended Ejection 6
No Apparent Adverse Event 6
Loose or Intermittent Connection 6
Fitting Problem 5
Occlusion Within Device 5
Bent 5
Device Operates Differently Than Expected 4
Infusion or Flow Problem 4
Material Integrity Problem 3
Device Dislodged or Dislocated 3
Activation, Positioning or Separation Problem 3
Material Deformation 3
Contamination of Device Ingredient or Reagent 3
Partial Blockage 3
Material Too Rigid or Stiff 3
Material Rupture 3
Short Fill 2
Device Markings / Labelling Problem 2
Packaging Problem 2
Improper Flow or Infusion 2
Defective Device 2
Unsealed Device Packaging 2
Device Handling Problem 2
Positioning Failure 2
Material Opacification 2
Mechanical Jam 2
Component Missing 2
Particulates 2
Connection Problem 2
Delivered as Unsterile Product 2
Device Ingredient or Reagent Problem 2
Material Twisted / Bent 2
Physical Resistance 2
Operating System Becomes Nonfunctional 1
Product Quality Problem 1
Explosion 1
Backflow 1
Contamination / decontamination Problem 1
Appropriate Term/Code Not Available 1
Degraded 1
Retraction Problem 1
Overcorrection 1
Disassembly 1
Material Separation 1
Incomplete or Missing Packaging 1
Complete Blockage 1
Pressure Problem 1
Chemical Spillage 1
Delivery System Failure 1
Ejection Problem 1
Noise, Audible 1
Positioning Problem 1
Disconnection 1
Fungus in Device Environment 1
Dull, Blunt 1
Malposition of device 1
Total Device Problems 6950

Recalls
Manufacturer Recall Class Date Posted
1 Merz North America, Inc. II Aug-19-2016
2 Merz North America, Inc. II Dec-03-2015
3 Orthovita, Inc., dBA Stryker Orthobiologics. II Mar-30-2015
4 Prollenium Medical Technologies Inc. II Feb-11-2020

-
-