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TPLC
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Device
tenaculum, uterine
Product Code
HDC
Regulation Number
884.4530
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
Hemorrhage/Bleeding
3
3
No Clinical Signs, Symptoms or Conditions
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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