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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tenaculum, uterine
Product CodeHDC
Regulation Number 884.4530
Device Class 2


Premarket Reviews
ManufacturerDecision
ASPIVIX S.A.
  SUBSTANTIALLY EQUIVALENT 1
ASPIVIX SA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 2 2
2021 4 4
2022 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4 4
Physical Resistance/Sticking 3 3
Failure to Clean Adequately 3 3
Device Contamination with Body Fluid 2 2
Microbial Contamination of Device 2 2
Misconnection 2 2
Residue After Decontamination 2 2
Detachment of Device or Device Component 2 2
Inadequate Instructions for Healthcare Professional 1 1
Device Reprocessing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 6 6
No Clinical Signs, Symptoms or Conditions 3 3
Hemorrhage/Bleeding 3 3
Exposure to Body Fluids 2 2
No Consequences Or Impact To Patient 2 2
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stradis Medical, LLC dba Stradis Healthcare II Oct-16-2021
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