TPLC - Total Product Life Cycle

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Device	acid, hyaluronic, intraarticular
Product Code	MOZ
Device Class	3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
22	20	20	13	11	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1304	1304
Insufficient Information	113	113
Patient-Device Incompatibility	109	109
Off-Label Use	55	55
Break	37	37
Therapeutic or Diagnostic Output Failure	31	31
Use of Device Problem	30	30
Patient Device Interaction Problem	28	28
Improper or Incorrect Procedure or Method	21	21
Appropriate Term/Code Not Available	17	17
Microbial Contamination of Device	14	14
No Apparent Adverse Event	9	9
Lack of Effect	9	9
Leak/Splash	8	8
Unexpected Therapeutic Results	6	6
Detachment of Device or Device Component	5	5
Fluid/Blood Leak	4	4
Output Problem	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Failure to Deliver	3	3
Fracture	3	3
Contamination /Decontamination Problem	2	2
Defective Device	2	2
Device Fell	2	2
Device Handling Problem	2	2
Product Quality Problem	2	2
Material Separation	2	2
Contamination of Device Ingredient or Reagent	2	2
Device Markings/Labelling Problem	2	2
Device Contamination with Chemical or Other Material	2	2
Device Appears to Trigger Rejection	2	2
Expiration Date Error	1	1
Material Integrity Problem	1	1
Shipping Damage or Problem	1	1
Misfire	1	1
Unintended Ejection	1	1
Component Missing	1	1
Application Program Problem: Medication Error	1	1
Device Damaged Prior to Use	1	1
Crack	1	1
Burst Container or Vessel	1	1
Migration	1	1
Explosion	1	1
Inaccurate Delivery	1	1
Device Dislodged or Dislocated	1	1
Protective Measures Problem	1	1
Activation, Positioning or Separation Problem	1	1
Nonstandard Device	1	1
Human-Device Interface Problem	1	1
Improper Chemical Reaction	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	398	398
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	324	324
Arthralgia	282	282
Ambulation Difficulties	256	256
Swelling/ Edema	242	242
Insufficient Information	239	239
No Code Available	156	156
No Clinical Signs, Symptoms or Conditions	114	114
Hypersensitivity/Allergic reaction	102	102
Joint Swelling	88	88
Arthritis	86	86
Rash	69	69
Inflammation	68	68
Unspecified Infection	64	64
Bacterial Infection	61	61
Loss of Range of Motion	60	60
Swelling	53	53
Synovitis	45	45
Headache	44	44
Erythema	41	41
Peripheral Edema	40	40
Cancer	39	39
Nausea	38	39
Dyspnea	37	37
Fever	35	35
No Known Impact Or Consequence To Patient	35	35
Itching Sensation	34	34
Fatigue	31	31
Injection Site Reaction	30	30
Therapeutic Response, Decreased	30	30
Death	25	25
Muscle Weakness	25	25
Dizziness	25	25
Discomfort	24	24
Sleep Dysfunction	23	23
Myalgia	22	22
Inadequate Pain Relief	21	21
Burning Sensation	20	20
Numbness	19	19
Thrombosis/Thrombus	19	19
Fall	18	18
High Blood Pressure/ Hypertension	17	17
Chills	16	16
Myocardial Infarction	16	16
Joint Disorder	15	15
Bone Fracture(s)	15	15
Malaise	15	15
Necrosis	15	15
Reaction	15	15
Shaking/Tremors	14	14