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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device applicator, vaginal
Product CodeHGD
Regulation Number 884.4520
Device Class 1

MDR Year MDR Reports MDR Events
2017 2 2
2018 1 1
2019 4 4
2020 1 1
2021 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 2 2
Insufficient Information 2 2
Sharp Edges 2 2
Device Difficult to Setup or Prepare 1 1
Inadequacy of Device Shape and/or Size 1 1
Calibration Problem 1 1
Connection Problem 1 1
Difficult to Open or Remove Packaging Material 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Scratched Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Blood Loss 2 2
No Known Impact Or Consequence To Patient 1 1
Genital Bleeding 1 1
Abrasion 1 1
Hypersensitivity/Allergic reaction 1 1
Laceration(s) 1 1
Pain 1 1
Urinary Tract Infection 1 1
Rupture 1 1
Complaint, Ill-Defined 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Carefusion 2200 Inc II Mar-14-2012
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