• 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 acid, hyaluronic, intraarticular
Product CodeMOZ
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
10 7 9 12 10 28 21 21 16 21 12 22 20 20 13 9

MDR Year MDR Reports MDR Events
2014 340 340
2015 293 293
2016 313 313
2017 506 506
2018 1096 1096
2019 567 567
2020 441 441
2021 375 375
2022 305 305
2023 471 471
2024 184 184

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2708 2708
Insufficient Information 552 552
Device Contamination With Biological Material 531 531
Patient-Device Incompatibility 425 425
Microbial Contamination of Device 176 176
Off-Label Use 118 118
Nonstandard Device 96 96
Device Operates Differently Than Expected 77 77
Appropriate Term/Code Not Available 75 75
Improper or Incorrect Procedure or Method 46 46
Break 38 38
Therapeutic or Diagnostic Output Failure 37 37
Use of Device Problem 36 36
No Apparent Adverse Event 29 29
Unexpected Therapeutic Results 24 24
Patient Device Interaction Problem 22 22
Leak/Splash 11 11
Manufacturing, Packaging or Shipping Problem 10 10
Lack of Effect 9 9
Contamination 7 7
Detachment of Device or Device Component 7 7
Device Markings/Labelling Problem 6 6
Product Quality Problem 6 6
Fluid/Blood Leak 5 5
Defective Device 5 5
Contamination of Device Ingredient or Reagent 5 5
Loss of Data 4 4
Application Program Problem: Medication Error 4 4
Output Problem 3 3
Device Fell 3 3
Missing Value Reason 3 3
Failure to Deliver 3 3
Material Separation 3 3
Device Inoperable 2 2
Device Appears to Trigger Rejection 2 2
Device Dislodged or Dislocated 2 2
Inaccurate Delivery 2 2
Fracture 2 2
Device Contamination with Chemical or Other Material 2 2
Device Handling Problem 2 2
Improper Flow or Infusion 2 2
Difficult to Insert 2 2
Contamination /Decontamination Problem 2 2
Patient Data Problem 2 2
Expiration Date Error 2 2
Defective Component 2 2
Unstable 2 2
Component Missing 1 1
Material Twisted/Bent 1 1
Material Too Rigid or Stiff 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1323 1323
Arthralgia 994 994
No Code Available 991 991
Joint Swelling 794 794
Swelling 695 695
Ambulation Difficulties 500 500
Joint Disorder 383 383
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 312 312
Arthritis 292 292
Inflammation 236 236
Hypersensitivity/Allergic reaction 229 229
Unspecified Infection 214 214
Swelling/ Edema 207 207
Insufficient Information 205 205
Reaction 171 171
Erythema 167 167
Reaction, Injection Site 165 165
Bacterial Infection 140 140
Synovitis 127 127
Fever 127 127
Loss of Range of Motion 123 123
Rash 118 118
No Known Impact Or Consequence To Patient 113 113
Death 109 109
Nausea 97 98
No Clinical Signs, Symptoms or Conditions 96 96
Headache 94 94
Discomfort 79 79
Dyspnea 77 77
Fatigue 77 77
Itching Sensation 76 76
Edema 71 71
Therapeutic Response, Decreased 71 71
Chills 69 69
Sleep Dysfunction 62 62
Dizziness 61 61
Fall 60 60
Inadequate Pain Relief 60 60
Fluid Discharge 57 57
Burning Sensation 54 54
Muscle Weakness 46 46
Toxicity 45 45
High Blood Pressure/ Hypertension 41 41
Peripheral Edema 40 40
Myalgia 40 40
Weakness 40 40
Numbness 39 39
Vomiting 39 39
Disability 36 36
Sepsis 35 35

Recalls
Manufacturer Recall Class Date Posted
1 Ferring Pharmaceuticals Inc III May-21-2010
2 Sanofi Genzyme II Feb-14-2018
-
-