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TPLC
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show TPLC since
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Device
pump, breast, non-powered
Product Code
HGY
Regulation Number
884.5150
Device Class
1
Premarket Reviews
Manufacturer
Decision
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
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
10
10
Adverse Event Without Identified Device or Use Problem
5
5
Decrease in Suction
5
5
Appropriate Term/Code Not Available
5
5
Suction Problem
5
5
Patient-Device Incompatibility
3
3
Inadequacy of Device Shape and/or Size
3
3
Device Operates Differently Than Expected
3
3
Fitting Problem
2
2
Device Slipped
1
1
Suction Failure
1
1
Kinked
1
1
Material Puncture/Hole
1
1
Infusion or Flow Problem
1
1
Contamination of Device Ingredient or Reagent
1
1
Gas/Air Leak
1
1
Failure to Power Up
1
1
Patient Device Interaction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
15
15
Breast Discomfort/Pain
6
6
No Code Available
4
4
Inflammation
4
4
Bacterial Infection
4
4
Rash
2
2
Electric Shock
1
1
Hypersensitivity/Allergic reaction
1
1
Skin Inflammation/ Irritation
1
1
No Known Impact Or Consequence To Patient
1
1
Injury
1
1
Erythema
1
1
Swelling
1
1
Insufficient Information
1
1
Laceration(s)
1
1
Reaction
1
1
Abscess
1
1
Skin Tears
1
1
Deformity/ Disfigurement
1
1
Bruise/Contusion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Ameda, Inc.
II
Mar-26-2015
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