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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device shield, nipple
Product CodeHFS
Regulation Number 880.5630
Device Class 1

MDR Year MDR Reports MDR Events
2014 5 5
2017 1 1
2018 1 1
2019 3 3
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Patient-Device Incompatibility 2 2
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Complete Blockage 1 1
Excess Flow or Over-Infusion 1 1
Inadequacy of Device Shape and/or Size 1 1
Fitting Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 4 4
Inflammation 3 3
Pain 3 3
No Code Available 2 2
Hypersensitivity/Allergic reaction 1 1
Swelling 1 1
Fungal Infection 1 1
Skin Tears 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medela Inc II Jun-10-2011
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