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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device syringe, periodontic, endodontic, irrigating
Product CodeEIC
Regulation Number 872.4565
Device Class 1

MDR Year MDR Reports MDR Events
2019 146 146
2020 35 35
2021 76 76
2022 11 11
2023 19 19
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Break 294 294
Inadequacy of Device Shape and/or Size 3 3
Entrapment of Device 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Fragmentation 1 1
Inaccurate Synchronization 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 126 126
No Consequences Or Impact To Patient 116 116
No Clinical Signs, Symptoms or Conditions 110 110
Insufficient Information 52 52
No Information 45 45
Device Embedded In Tissue or Plaque 20 20
Foreign Body In Patient 6 6
Perforation 2 2
Sinus Perforation 2 2
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
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