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 acid, hyaluronic, intraarticular
Product CodeMOZ
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023
21 12 22 20 20 8

MDR Year MDR Reports MDR Events
2018 1096 1096
2019 567 567
2020 441 441
2021 375 375
2022 305 305
2023 204 204

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1739 1739
Device Contamination With Biological Material 441 441
Patient-Device Incompatibility 240 240
Insufficient Information 164 164
Microbial Contamination of Device 163 163
Off-Label Use 105 105
Nonstandard Device 71 71
Appropriate Term/Code Not Available 36 36
Therapeutic or Diagnostic Output Failure 34 34
Improper or Incorrect Procedure or Method 34 34
Use of Device Problem 28 28
Patient Device Interaction Problem 20 20
Break 11 11
Unexpected Therapeutic Results 10 10
Manufacturing, Packaging or Shipping Problem 10 10
Device Operates Differently Than Expected 9 9
Leak/Splash 8 8
Detachment of Device or Device Component 7 7
No Apparent Adverse Event 6 6
Device Markings/Labelling Problem 5 5
Lack of Effect 5 5
Defective Device 5 5
Contamination of Device Ingredient or Reagent 4 4
Loss of Data 4 4
Fluid/Blood Leak 4 4
Contamination 4 4
Product Quality Problem 4 4
Failure to Deliver 3 3
Device Fell 3 3
Device Dislodged or Dislocated 2 2
Device Contamination with Chemical or Other Material 2 2
Output Problem 2 2
Missing Value Reason 2 2
Inaccurate Delivery 2 2
Defective Component 2 2
Expiration Date Error 2 2
Device Appears to Trigger Rejection 2 2
Material Separation 2 2
Shipping Damage or Problem 1 1
Device Slipped 1 1
Device Inoperable 1 1
Unstable 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Too Rigid or Stiff 1 1
Therapy Delivered to Incorrect Body Area 1 1
No Display/Image 1 1
Unintended Ejection 1 1
Burst Container or Vessel 1 1
Fracture 1 1
Misfire 1 1
Contamination /Decontamination Problem 1 1
Activation, Positioning or Separation Problem 1 1
Device Damaged Prior to Use 1 1
Tear, Rip or Hole in Device Packaging 1 1
Component Missing 1 1
Patient Data Problem 1 1
Application Program Problem: Medication Error 1 1
Protective Measures Problem 1 1
Human-Device Interface Problem 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 812 812
Pain 783 783
Arthralgia 687 687
Joint Swelling 482 482
Swelling 373 373
Ambulation Difficulties 293 293
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 212 212
Joint Disorder 188 188
Swelling/ Edema 158 158
Arthritis 158 158
Insufficient Information 155 155
Reaction, Injection Site 122 122
Hypersensitivity/Allergic reaction 121 121
Inflammation 120 120
Unspecified Infection 110 110
No Known Impact Or Consequence To Patient 107 107
Erythema 97 97
Loss of Range of Motion 91 91
Bacterial Infection 90 90
Fever 79 79
Synovitis 79 79
Rash 76 76
Death 75 75
Nausea 62 63
Therapeutic Response, Decreased 59 59
Reaction 57 57
Fatigue 56 56
Discomfort 54 54
Headache 49 49
Chills 47 47
Sleep Dysfunction 45 45
Dyspnea 44 44
Itching Sensation 43 43
Fall 42 42
Dizziness 40 40
Edema 38 38
Toxicity 36 36
Burning Sensation 36 36
Muscle Weakness 33 33
Weakness 30 30
Muscle Spasm(s) 29 29
Inadequate Pain Relief 28 28
Myalgia 27 27
Numbness 25 25
Urticaria 24 24
No Clinical Signs, Symptoms or Conditions 23 23
Malaise 21 21
No Information 21 21
Vomiting 20 20
Injury 20 20
Shaking/Tremors 19 19
High Blood Pressure/ Hypertension 19 19
Cyst(s) 19 19
Sepsis 17 17
Disability 17 17
Skin Inflammation 16 16
Loss of consciousness 15 15
Injection Site Reaction 15 15
Sweating 15 15
Aspiration/Inhalation 15 15
Cancer 14 14
Diarrhea 13 13
Hypoesthesia 13 13
Peripheral Edema 13 13
Bone Fracture(s) 13 13
Muscular Rigidity 13 13
Abdominal Pain 13 13
Skin Discoloration 13 13
Alteration In Body Temperature 13 13
Complaint, Ill-Defined 12 12
Thrombosis/Thrombus 12 12
Myocardial Infarction 12 12
Necrosis 12 12
Local Reaction 11 11
Paralysis 11 11
Neck Stiffness 11 11
Missed Dose 11 11
Arrhythmia 10 10
Anxiety 10 10
Cramp(s) /Muscle Spasm(s) 10 10
Atrial Fibrillation 10 10
Anaphylactic Shock 10 10
Hyperglycemia 9 9
Chest Pain 9 9
Balance Problems 9 9
Neck Pain 9 9
Hot Flashes/Flushes 9 9
Cramp(s) 9 9
Thrombosis 8 8
Stroke/CVA 8 8
Therapeutic Effects, Unexpected 8 8
Syncope 8 8
Neuropathy 8 8
Hemorrhage/Bleeding 8 8
Tingling 8 8
Fluid Discharge 8 8
Low Blood Pressure/ Hypotension 7 7
Blurred Vision 7 7
Bruise/Contusion 7 7
Patient Problem/Medical Problem 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Sanofi Genzyme II Feb-14-2018
-
-