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TPLC
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show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
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Device
acid, hyaluronic, intraarticular
Product Code
MOZ
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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