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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device saliva, artificial
Product CodeLFD
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
EUSA PHARMA (UK) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GURUNANDA LLC
  SUBSTANTIALLY EQUIVALENT 1
LACLEDE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORALABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OXY2PLUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SUNBIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
THE PROCTER & GAMBLE COMPANY
  SUBSTANTIALLY EQUIVALENT 2
TRIUMPH PHARMACEUTICALS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 40 40
2020 34 34
2021 30 30
2022 15 15
2023 10 10
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 118 118
Product Quality Problem 9 9
Patient-Device Incompatibility 6 6
Improper or Incorrect Procedure or Method 3 3
Inadequate Instructions for Non-Healthcare Professional 1 1
Off-Label Use 1 1
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 44 44
No Code Available 23 23
Choking 21 21
Dyspnea 5 5
Burning Sensation 5 5
Stroke/CVA 4 4
Death 4 4
Reaction 4 4
Pain 4 4
Insufficient Information 4 4
Cough 3 3
Discomfort 3 3
Vomiting 3 3
Swelling 3 3
Cataract 3 3
Loss of consciousness 2 2
Hemorrhage/Bleeding 2 2
Myocardial Infarction 2 2
Swelling/ Edema 2 2
Sjogren's Syndrome 2 2
Dysphagia/ Odynophagia 2 2
Anaphylactic Shock 2 2
Numbness 2 2
Asthma 2 2
Seizures 2 2
Nausea 2 2
Tingling 2 2
Unspecified Infection 2 2
Taste Disorder 1 1
Reaction to Medicinal Component of Device 1 1
Paresthesia 1 1
Weakness 1 1
Inflammation 1 1
Foreign Body In Patient 1 1
Erythema 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Sepsis 1 1
Respiratory Distress 1 1
Emotional Changes 1 1
Dry Mouth 1 1
Coma 1 1
Sweating 1 1
Complaint, Ill-Defined 1 1
Hypersensitivity/Allergic reaction 1 1
Arrhythmia 1 1
Stenosis 1 1
Anxiety 1 1
Apnea 1 1
Salivary Hypersecretion 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Sunstar Americas, Inc. II Mar-05-2021
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