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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)
2016 2017 2018 2019 2020 2021
21 16 21 12 22 19

MDR Year MDR Reports MDR Events
2016 313 313
2017 506 506
2018 1096 1096
2019 567 567
2020 441 441
2021 330 330

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1897 1897
Device Contamination With Biological Material 531 531
Patient-Device Incompatibility 256 256
Insufficient Information 239 239
Microbial Contamination of Device 171 171
Nonstandard Device 95 95
Off-Label Use 95 95
Appropriate Term/Code Not Available 56 56
Therapeutic or Diagnostic Output Failure 31 31
Device Operates Differently Than Expected 31 31
Improper or Incorrect Procedure or Method 26 26
No Apparent Adverse Event 20 20
Manufacturing, Packaging or Shipping Problem 9 9
Unexpected Therapeutic Results 9 9
Patient Device Interaction Problem 8 8
Leak/Splash 6 6
Use of Device Problem 6 6
Break 6 6
Product Quality Problem 5 5
Detachment of Device or Device Component 5 5
Device Markings/Labelling Problem 5 5
Defective Device 4 4
Loss of Data 4 4
Contamination 4 4
Contamination of Device Ingredient or Reagent 3 3
Application Program Problem: Medication Error 3 3
Missing Value Reason 3 3
Device Fell 2 2
Device Dislodged or Dislocated 2 2
Device Contamination with Chemical or Other Material 2 2
Fluid Leak 2 2
Device Appears to Trigger Rejection 2 2
Material Separation 2 2
Expiration Date Error 2 2
Failure to Deliver 2 2
Unstable 2 2
Defective Component 2 2
Invalid Sensing 1 1
Device Damaged Prior to Use 1 1
Aborted Charge 1 1
Device Inoperable 1 1
Inaccurate Delivery 1 1
Tear, Rip or Hole in Device Packaging 1 1
Component Missing 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Shipping Damage or Problem 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Material Too Rigid or Stiff 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
No Display/Image 1 1
Burst Container or Vessel 1 1
Human Factors Issue 1 1
Human-Device Interface Problem 1 1
Improper Device Output 1 1
Improper Flow or Infusion 1 1
Activation, Positioning or SeparationProblem 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Output Problem 1 1
Protective Measures Problem 1 1
Noise, Audible 1 1
Patient Data Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 965 965
Pain 874 874
Arthralgia 844 844
Joint Swelling 669 669
Swelling 506 506
Joint Disorder 349 349
Ambulation Difficulties 259 259
Arthritis 195 195
Reaction, Injection Site 155 155
Hypersensitivity/Allergic reaction 139 139
Inflammation 136 136
Unspecified Infection 134 134
Erythema 126 126
No Known Impact Or Consequence To Patient 111 111
Reaction 103 103
Fever 96 96
Death 89 89
Bacterial Infection 87 87
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 87 87
Synovitis 85 85
Loss of Range of Motion 84 84
Rash 81 81
Swelling/ Edema 71 71
Nausea 69 70
Therapeutic Response, Decreased 60 60
Headache 57 57
Fatigue 57 57
Itching Sensation 55 55
Chills 55 55
Insufficient Information 51 51
Discomfort 48 48
Edema 48 48
Toxicity 45 45
Sleep Dysfunction 45 45
Dyspnea 44 44
Fall 44 44
Burning Sensation 41 41
Dizziness 41 41
Inadequate Pain Relief 37 37
Weakness 34 34
Muscle Spasm(s) 32 32
Injury 28 28
Urticaria 27 27
Muscle Weakness 27 27
Myalgia 26 26
No Information 26 26
Malaise 25 25
Disability 24 24
Vomiting 24 24
High Blood Pressure/ Hypertension 23 23
Cyst(s) 23 23
Numbness 22 22
Sweating 22 22
Shaking/Tremors 20 20
Complaint, Ill-Defined 20 20
Sepsis 20 20
Alteration In Body Temperature 18 18
Skin Inflammation 17 17
Loss of consciousness 17 17
Diarrhea 17 17
Muscular Rigidity 16 16
Skin Discoloration 15 15
Bone Fracture(s) 15 15
Aspiration/Inhalation 15 15
Cramp(s) 15 15
Hypoesthesia 14 14
Tingling 12 12
Paralysis 12 12
Hemorrhage/Bleeding 11 11
Thrombosis 11 11
Chest Pain 11 11
Anaphylactic Shock 11 11
Cellulitis 11 11
Anxiety 11 11
Confusion/ Disorientation 11 11
Missed Dose 11 11
No Clinical Signs, Symptoms or Conditions 11 11
Palpitations 10 10
Limited Mobility Of The Implanted Joint 10 10
Therapeutic Effects, Unexpected 10 10
Hot Flashes/Flushes 10 10
Abdominal Pain 10 10
Respiratory Distress 10 10
Tachycardia 9 9
Urinary Tract Infection 9 9
Necrosis 9 9
Myocardial Infarction 9 9
Arrhythmia 9 9
Neck Stiffness 9 9
Patient Problem/Medical Problem 9 9
Fluid Discharge 8 8
Test Result 8 8
Weight Changes 8 8
Cancer 8 8
Neck Pain 8 8
Syncope 8 8
Stroke/CVA 8 8
Fainting 8 8
Local Reaction 8 8
Memory Loss/Impairment 8 8

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