TPLC - Total Product Life Cycle

show TPLC since

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	9

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	2708	2708
Insufficient Information	552	552
Device Contamination With Biological Material	531	531
Patient-Device Incompatibility	425	425
Microbial Contamination of Device	176	176
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	46	46
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
Contamination	7	7
Detachment of Device or Device Component	7	7
Device Markings/Labelling Problem	6	6
Product Quality Problem	6	6
Fluid/Blood Leak	5	5
Defective Device	5	5
Contamination of Device Ingredient or Reagent	5	5
Loss of Data	4	4
Application Program Problem: Medication Error	4	4
Output Problem	3	3
Device Fell	3	3
Missing Value Reason	3	3
Failure to Deliver	3	3
Material Separation	3	3
Device Inoperable	2	2
Device Appears to Trigger Rejection	2	2
Device Dislodged or Dislocated	2	2
Inaccurate Delivery	2	2
Fracture	2	2
Device Contamination with Chemical or Other Material	2	2
Device Handling Problem	2	2
Improper Flow or Infusion	2	2
Difficult to Insert	2	2
Contamination /Decontamination Problem	2	2
Patient Data Problem	2	2
Expiration Date Error	2	2
Defective Component	2	2
Unstable	2	2
Component Missing	1	1
Material Twisted/Bent	1	1
Material Too Rigid or Stiff	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	1323	1323
Arthralgia	994	994
No Code Available	991	991
Joint Swelling	794	794
Swelling	695	695
Ambulation Difficulties	500	500
Joint Disorder	383	383
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	312	312
Arthritis	292	292
Inflammation	236	236
Hypersensitivity/Allergic reaction	229	229
Unspecified Infection	214	214
Swelling/ Edema	207	207
Insufficient Information	205	205
Reaction	171	171
Erythema	167	167
Reaction, Injection Site	165	165
Bacterial Infection	140	140
Synovitis	127	127
Fever	127	127
Loss of Range of Motion	123	123
Rash	118	118
No Known Impact Or Consequence To Patient	113	113
Death	109	109
Nausea	97	98
No Clinical Signs, Symptoms or Conditions	96	96
Headache	94	94
Discomfort	79	79
Dyspnea	77	77
Fatigue	77	77
Itching Sensation	76	76
Edema	71	71
Therapeutic Response, Decreased	71	71
Chills	69	69
Sleep Dysfunction	62	62
Dizziness	61	61
Fall	60	60
Inadequate Pain Relief	60	60
Fluid Discharge	57	57
Burning Sensation	54	54
Muscle Weakness	46	46
Toxicity	45	45
High Blood Pressure/ Hypertension	41	41
Peripheral Edema	40	40
Myalgia	40	40
Weakness	40	40
Numbness	39	39
Vomiting	39	39
Disability	36	36
Sepsis	35	35

Recalls
Manufacturer		Recall Class	Date Posted
1	Ferring Pharmaceuticals Inc	III	May-21-2010
2	Sanofi Genzyme	II	Feb-14-2018