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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pump, breast, non-powered
Product CodeHGY
Regulation Number 884.5150
Device Class 1


Premarket Reviews
ManufacturerDecision
PHILIPS ELECTRONICS UK LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 7 7
2015 9 9
2016 7 7
2017 4 4
2018 3 3
2019 1 1
2020 2 2
2021 5 5
2022 1 1
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 10 10
Appropriate Term/Code Not Available 5 5
Decrease in Suction 5 5
Suction Problem 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Inadequacy of Device Shape and/or Size 3 3
Patient-Device Incompatibility 3 3
Device Operates Differently Than Expected 3 3
Fitting Problem 2 2
Device Slipped 1 1
Kinked 1 1
Failure to Power Up 1 1
Material Puncture/Hole 1 1
Gas/Air Leak 1 1
Infusion or Flow Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Patient Device Interaction Problem 1 1
Suction Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 15 15
Breast Discomfort/Pain 5 5
Inflammation 4 4
No Code Available 4 4
Bacterial Infection 4 4
Rash 2 2
Swelling 1 1
Injury 1 1
Deformity/ Disfigurement 1 1
Reaction 1 1
Skin Tears 1 1
Electric Shock 1 1
No Known Impact Or Consequence To Patient 1 1
Bruise/Contusion 1 1
Erythema 1 1
Hypersensitivity/Allergic reaction 1 1
Abscess 1 1
Laceration(s) 1 1
Skin Inflammation/ Irritation 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ameda, Inc. II Mar-26-2015
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