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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sound, uterine
Product CodeHHM
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
Hole In Material 1 1
Difficult To Position 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Fire 1 1
Device Inoperable 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation 13 13
Uterine Perforation 9 9
No Consequences Or Impact To Patient 3 3
Internal Organ Perforation 3 3
No Known Impact Or Consequence To Patient 3 3
Device Embedded In Tissue or Plaque 2 2
No Information 2 2
No Code Available 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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