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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 9

MDR Year MDR Reports MDR Events
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 1544 1544
Patient-Device Incompatibility 172 172
Insufficient Information 115 115
Off-Label Use 109 109
Microbial Contamination of Device 51 51
Break 36 36
Therapeutic or Diagnostic Output Failure 32 32
Improper or Incorrect Procedure or Method 31 31
Use of Device Problem 31 31
Patient Device Interaction Problem 22 22
Appropriate Term/Code Not Available 21 21
Leak/Splash 9 9
Unexpected Therapeutic Results 9 9
No Apparent Adverse Event 9 9
Lack of Effect 9 9
Detachment of Device or Device Component 7 7
Manufacturing, Packaging or Shipping Problem 6 6
Fluid/Blood Leak 4 4
Output Problem 3 3
Device Markings/Labelling Problem 3 3
Nonstandard Device 3 3
Defective Device 3 3
Failure to Deliver 3 3
Device Appears to Trigger Rejection 2 2
Fracture 2 2
Device Contamination with Chemical or Other Material 2 2
Contamination of Device Ingredient or Reagent 2 2
Material Separation 2 2
Product Quality Problem 2 2
Device Handling Problem 2 2
Contamination /Decontamination Problem 2 2
Expiration Date Error 2 2
Defective Component 2 2
Device Fell 2 2
Application Program Problem: Medication Error 1 1
Material Twisted/Bent 1 1
Component Missing 1 1
Material Too Rigid or Stiff 1 1
Unintended Ejection 1 1
Misfire 1 1
Shipping Damage or Problem 1 1
Patient Data Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Explosion 1 1
Inaccurate Delivery 1 1
Device Dislodged or Dislocated 1 1
Protective Measures Problem 1 1
Device Damaged Prior to Use 1 1
Burst Container or Vessel 1 1
Activation, Positioning or Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 477 477
Arthralgia 415 415
No Code Available 397 397
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 306 306
Ambulation Difficulties 239 239
Joint Swelling 219 219
Insufficient Information 205 205
Swelling/ Edema 203 203
Hypersensitivity/Allergic reaction 120 120
Arthritis 111 111
No Known Impact Or Consequence To Patient 100 100
No Clinical Signs, Symptoms or Conditions 96 96
Swelling 92 92
Inflammation 90 90
Rash 72 72
Loss of Range of Motion 64 64
Unspecified Infection 61 61
Joint Disorder 58 58
Bacterial Infection 54 54
Synovitis 53 53
Headache 52 52
Therapeutic Response, Decreased 47 47
Dyspnea 46 46
Death 45 45
Erythema 45 45
Nausea 44 45
Fever 42 42
Itching Sensation 41 41
Fatigue 40 40
Peripheral Edema 39 39
Sleep Dysfunction 37 37
Discomfort 30 30
Muscle Weakness 30 30
Myalgia 29 29
Cancer 29 29
Reaction 29 29
Chills 28 28
Dizziness 28 28
Reaction, Injection Site 27 27
Burning Sensation 26 26
Inadequate Pain Relief 26 26
Injection Site Reaction 21 21
Edema 20 20
Thrombosis/Thrombus 19 19
Malaise 19 19
Fall 19 19
Urticaria 19 19
High Blood Pressure/ Hypertension 19 19
Numbness 18 18
Myocardial Infarction 17 17

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