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TPLC
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show TPLC since
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Device
sound, uterine
Product Code
HHM
Regulation Number
884.4530
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
7
7
2015
6
6
2016
8
8
2017
3
3
2018
5
5
2019
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
10
10
Insufficient Information
8
8
Break
6
6
Device Operates Differently Than Expected
5
5
Device Handling Problem
2
2
Therapeutic or Diagnostic Output Failure
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Difficult To Position
1
1
Failure to Fire
1
1
Device Inoperable
1
1
Improper or Incorrect Procedure or Method
1
1
Hole In Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Perforation
13
13
Uterine Perforation
9
9
No Known Impact Or Consequence To Patient
3
3
No Consequences Or Impact To Patient
3
3
Internal Organ Perforation
3
3
No Code Available
2
2
No Information
2
2
Device Embedded In Tissue or Plaque
2
2
Pain
1
1
Tissue Damage
1
1
Therapeutic Response, Decreased
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Centurion Medical Products Corporation
II
Feb-05-2020
2
Hologic, Inc
II
Nov-22-2016
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