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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 4

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 75 75

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2656 2656
Insufficient Information 548 548
Device Contamination With Biological Material 531 531
Patient-Device Incompatibility 425 425
Microbial Contamination of Device 175 175
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 45 45
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
Detachment of Device or Device Component 7 7
Contamination 7 7
Product Quality Problem 6 6
Device Markings/Labelling Problem 6 6
Contamination of Device Ingredient or Reagent 5 5
Defective Device 5 5
Fluid/Blood Leak 5 5
Loss of Data 4 4
Application Program Problem: Medication Error 4 4
Device Fell 3 3
Output Problem 3 3
Missing Value Reason 3 3
Material Separation 3 3
Failure to Deliver 3 3
Inaccurate Delivery 2 2
Expiration Date Error 2 2
Defective Component 2 2
Device Appears to Trigger Rejection 2 2
Device Inoperable 2 2
Unstable 2 2
Fracture 2 2
Difficult to Insert 2 2
Patient Data Problem 2 2
Device Handling Problem 2 2
Contamination /Decontamination Problem 2 2
Improper Flow or Infusion 2 2
Device Dislodged or Dislocated 2 2
Device Contamination with Chemical or Other Material 2 2
Human Factors Issue 1 1
Human-Device Interface Problem 1 1
Improper Device Output 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Noise, Audible 1 1
Explosion 1 1
Protective Measures Problem 1 1
Burst Container or Vessel 1 1
Disconnection 1 1
No Display/Image 1 1
Unintended Ejection 1 1
Therapy Delivered to Incorrect Body Area 1 1
Incorrect Software Programming Calculations 1 1
Partial Blockage 1 1
Overheating of Device 1 1
Particulates 1 1
Device Damaged Prior to Use 1 1
Aborted Charge 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Too Rigid or Stiff 1 1
Shipping Damage or Problem 1 1
Device Slipped 1 1
Invalid Sensing 1 1
Component Missing 1 1
Misfire 1 1
Tear, Rip or Hole in Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1301 1301
No Code Available 991 991
Arthralgia 985 985
Joint Swelling 794 794
Swelling 695 695
Ambulation Difficulties 483 483
Joint Disorder 383 383
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 289 289
Arthritis 285 285
Inflammation 233 233
Hypersensitivity/Allergic reaction 223 223
Unspecified Infection 214 214
Insufficient Information 193 193
Swelling/ Edema 193 193
Reaction 171 171
Reaction, Injection Site 165 165
Erythema 161 161
Bacterial Infection 134 134
Synovitis 127 127
Fever 126 126
Loss of Range of Motion 118 118
Rash 116 116
No Known Impact Or Consequence To Patient 113 113
Death 109 109
Nausea 95 96
Headache 94 94
No Clinical Signs, Symptoms or Conditions 81 81
Discomfort 78 78
Fatigue 76 76
Dyspnea 75 75
Itching Sensation 72 72
Edema 71 71
Therapeutic Response, Decreased 71 71
Chills 69 69
Sleep Dysfunction 62 62
Dizziness 60 60
Fall 60 60
Inadequate Pain Relief 59 59
Fluid Discharge 56 56
Burning Sensation 54 54
Toxicity 45 45
Muscle Weakness 44 44
High Blood Pressure/ Hypertension 41 41
Weakness 40 40
Myalgia 40 40
Numbness 39 39
Vomiting 37 37
Disability 36 36
Sepsis 35 35
Muscle Spasm(s) 34 34
Alteration In Body Temperature 34 34
Complaint, Ill-Defined 34 34
Urticaria 34 34
Peripheral Edema 34 34
Injury 33 33
Malaise 33 33
Cancer 31 31
No Information 30 30
Shaking/Tremors 30 30
Cyst(s) 27 27
Diarrhea 27 27
Sweating 26 26
Loss of consciousness 25 25
Muscular Rigidity 25 25
Test Result 24 24
Limited Mobility Of The Implanted Joint 23 23
Skin Discoloration 23 23
Necrosis 21 21
Hemorrhage/Bleeding 21 21
Aspiration/Inhalation 21 21
Bone Fracture(s) 20 20
Local Reaction 20 20
Skin Inflammation 20 20
Injection Site Reaction 20 20
Cellulitis 19 19
Chest Pain 18 18
Paralysis 18 18
Cramp(s) 18 18
Thrombosis 17 17
Myocardial Infarction 17 17
Thrombosis/Thrombus 16 16
Stroke/CVA 15 15
Anaphylactic Shock 15 15
Abdominal Pain 14 14
Atrial Fibrillation 14 14
Hyperglycemia 14 14
Hot Flashes/Flushes 14 14
Hypoesthesia 14 14
Anxiety 14 14
Tingling 13 13
Tachycardia 13 13
Cramp(s) /Muscle Spasm(s) 13 13
Neck Pain 12 12
Neck Stiffness 12 12
Confusion/ Disorientation 12 12
Arrhythmia 12 12
Bruise/Contusion 11 11
Memory Loss/Impairment 11 11
Respiratory Distress 11 11
Missed Dose 11 11

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