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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device needle, biopsy, cardiovascular
Regulation Description Manual surgical instrument for general use.
Product CodeDWO
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Insufficient Information 1 1
Failure to Obtain Sample 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pneumothorax 5 5
No Clinical Signs, Symptoms or Conditions 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 M.D.L. S.r.l. II Sep-20-2021
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