TPLC - Total Product Life Cycle

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Device	adhesive, denture, polyvinyl methylether maleic acid calcium-sodium double salt
Regulation Description	Carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive.
Product Code	KOO
Regulation Number	872.3490
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	21	21
Appropriate Term/Code Not Available	14	14
Product Quality Problem	10	10
Insufficient Information	2	2
Adhesive Too Strong	2	2
Device Dislodged or Dislocated	2	2
Device Markings/Labelling Problem	1	1
Patient-Device Incompatibility	1	1
Therapeutic or Diagnostic Output Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	32	32
Cough	8	8
Choking	7	7
Foreign Body In Patient	4	4
Dyspnea	4	4
Pneumonia	4	4
High Blood Pressure/ Hypertension	3	3
Weight Changes	3	3
Nausea	3	3
Unspecified Gastrointestinal Problem	3	3
Swelling/ Edema	3	3
Vomiting	3	3
Pain	3	3
Fatigue	2	2
Airway Obstruction	2	2
Constipation	2	2
Cancer	2	2
Anemia	2	2
Sore Throat	2	2
Hemorrhage/Bleeding	2	2
Tooth Fracture	2	2
Chronic Obstructive Pulmonary Disease (COPD)	2	2
Discomfort	2	2
Dysphagia/ Odynophagia	2	2
Stomatitis	1	1
Decreased Respiratory Rate	1	1
Eczema	1	1
Fibrosis	1	1
Irregular Pulse	1	1
Loss of consciousness	1	1
Bacterial Infection	1	1
Skin Tears	1	1
Myocardial Infarction	1	1
Hypoxia	1	1
Feeding Problem	1	1
Salivary Hypersecretion	1	1
Shaking/Tremors	1	1
Anaphylactic Shock	1	1
Dehydration	1	1
Numbness	1	1
Stomach Ulceration	1	1
Burning Sensation	1	1
Paralysis	1	1
Blister	1	1
Patch Test, Abnormal Results Of	1	1
Obstruction/Occlusion	1	1
Pharyngitis	1	1
Gastritis	1	1
Taste Disorder	1	1
Malaise	1	1