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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)
2019 2020 2021 2022 2023 2024
12 22 20 20 13 4

MDR Year MDR Reports MDR Events
2019 567 567
2020 441 441
2021 375 375
2022 305 305
2023 471 471
2024 102 102

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1505 1505
Patient-Device Incompatibility 172 172
Insufficient Information 112 112
Off-Label Use 109 109
Microbial Contamination of Device 51 51
Break 36 36
Therapeutic or Diagnostic Output Failure 32 32
Use of Device Problem 31 31
Improper or Incorrect Procedure or Method 30 30
Patient Device Interaction Problem 22 22
Appropriate Term/Code Not Available 21 21
No Apparent Adverse Event 9 9
Lack of Effect 9 9
Unexpected Therapeutic Results 9 9
Leak/Splash 9 9
Detachment of Device or Device Component 7 7
Manufacturing, Packaging or Shipping Problem 6 6
Fluid/Blood Leak 4 4
Nonstandard Device 3 3
Device Markings/Labelling Problem 3 3
Failure to Deliver 3 3
Defective Device 3 3
Output Problem 3 3
Device Handling Problem 2 2
Device Fell 2 2
Defective Component 2 2
Expiration Date Error 2 2
Device Contamination with Chemical or Other Material 2 2
Contamination /Decontamination Problem 2 2
Contamination of Device Ingredient or Reagent 2 2
Product Quality Problem 2 2
Fracture 2 2
Device Appears to Trigger Rejection 2 2
Material Separation 2 2
Shipping Damage or Problem 1 1
Device Slipped 1 1
Material Too Rigid or Stiff 1 1
Unstable 1 1
Device Damaged Prior to Use 1 1
Burst Container or Vessel 1 1
Unintended Ejection 1 1
Therapy Delivered to Incorrect Body Area 1 1
Activation, Positioning or Separation Problem 1 1
Human-Device Interface Problem 1 1
Device Dislodged or Dislocated 1 1
Misfire 1 1
Inaccurate Delivery 1 1
Tear, Rip or Hole in Device Packaging 1 1
Component Missing 1 1
Explosion 1 1
Protective Measures Problem 1 1
Material Twisted/Bent 1 1
Patient Data Problem 1 1
Application Program Problem: Medication Error 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 459 459
Arthralgia 408 408
No Code Available 397 397
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 288 288
Ambulation Difficulties 227 227
Joint Swelling 219 219
Insufficient Information 195 195
Swelling/ Edema 192 192
Hypersensitivity/Allergic reaction 115 115
Arthritis 106 106
No Known Impact Or Consequence To Patient 100 100
Swelling 92 92
Inflammation 87 87
No Clinical Signs, Symptoms or Conditions 86 86
Rash 72 72
Loss of Range of Motion 62 62
Unspecified Infection 61 61
Joint Disorder 58 58
Synovitis 53 53
Headache 52 52
Bacterial Infection 49 49
Therapeutic Response, Decreased 47 47
Death 45 45
Dyspnea 44 44
Erythema 44 44
Nausea 43 44
Fever 41 41
Fatigue 39 39
Itching Sensation 37 37
Sleep Dysfunction 37 37
Peripheral Edema 34 34
Discomfort 29 29
Myalgia 29 29
Reaction 29 29
Muscle Weakness 29 29
Chills 28 28
Dizziness 28 28
Reaction, Injection Site 27 27
Cancer 27 27
Burning Sensation 26 26
Inadequate Pain Relief 25 25
Injection Site Reaction 20 20
Edema 20 20
Fall 19 19
High Blood Pressure/ Hypertension 19 19
Urticaria 19 19
Numbness 18 18
Thrombosis/Thrombus 18 18
Malaise 17 17
Myocardial Infarction 16 16
Local Reaction 16 16
Necrosis 15 15
Vomiting 15 15
Shaking/Tremors 14 14
Cramp(s) /Muscle Spasm(s) 13 13
Muscle Spasm(s) 13 13
Cyst(s) 13 13
Stroke/CVA 12 12
Abdominal Pain 12 12
Loss of consciousness 12 12
Injury 12 12
Anaphylactic Shock 11 11
Paralysis 11 11
Weakness 10 10
Hot Flashes/Flushes 10 10
Skin Discoloration 10 10
Arrhythmia 10 10
Diarrhea 10 10
Bone Fracture(s) 10 10
Balance Problems 10 10
Hypoesthesia 9 9
No Information 9 9
Neuropathy 9 9
Sepsis 8 8
Tingling 8 8
Atrial Fibrillation 8 8
Sweating 8 8
Unspecified Tissue Injury 8 8
Syncope/Fainting 7 7
Convulsion/Seizure 7 7
Pulmonary Embolism 7 7
Bruise/Contusion 7 7
Hemorrhage/Bleeding 7 7
Therapeutic Effects, Unexpected 7 7
Hyperglycemia 6 6
Breast Cancer 6 6
Cardiomyopathy 6 6
Chest Pain 6 6
Anemia 6 6
Movement Disorder 6 6
Cardiovascular Insufficiency 6 6
Heart Failure/Congestive Heart Failure 6 6
Unspecified Gastrointestinal Problem 6 6
Hormonal Imbalance 6 6
Angioedema 6 6
Skin Inflammation/ Irritation 6 6
Skin Inflammation 6 6
Neck Pain 6 6
Confusion/ Disorientation 6 6
Complaint, Ill-Defined 6 6

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