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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, drainage, intraoral/extraoral
Definition To allow continuous drainage of saliva and/or fluid irrigation of the salivary duct as well as assisting in maintaining duct patency during the healing process following removal of salivary gland stones for temporary insertion into the salivary gland, whether orally or through the cheek following endoscopic or surgical removal of salivary gland stones
Product CodeOAJ
Regulation Number 878.4200
Device Class 1

MDR Year MDR Reports MDR Events
2017 1 1
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Dull, Blunt 1 1
Device Operates Differently Than Expected 1 1
No Flow 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pneumothorax 1 1
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1

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