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TPLC
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show TPLC since
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2024
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Device
speculum, vaginal, metal
Product Code
HDF
Regulation Number
884.4520
Device Class
1
MDR Year
MDR Reports
MDR Events
2016
1
1
2017
1
1
2018
1
1
2019
12
12
2020
3
3
2021
2
2
2022
3
3
2023
2
2
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Integrity Problem
4
4
Break
3
3
Incorrect, Inadequate or Imprecise Result or Readings
3
3
Peeled/Delaminated
2
2
Material Separation
2
2
Separation Problem
1
1
Material Split, Cut or Torn
1
1
Material Puncture/Hole
1
1
Insufficient Information
1
1
Material Fragmentation
1
1
Degraded
1
1
Problem with Sterilization
1
1
Device Markings/Labelling Problem
1
1
Defective Device
1
1
Therapeutic or Diagnostic Output Failure
1
1
Use of Device Problem
1
1
Device Emits Odor
1
1
Detachment of Device or Device Component
1
1
Nonstandard Device
1
1
Naturally Worn
1
1
Overheating of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
16
16
No Clinical Signs, Symptoms or Conditions
7
7
Insufficient Information
4
4
Burn, Thermal
1
1
Laceration(s)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Carefusion 2200 Inc
II
Apr-21-2023
2
Centurion Medical Products Corporation
II
Aug-06-2019
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