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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pump, breast, powered
Product CodeHGX
Regulation Number 884.5160
Device Class 2


Premarket Reviews
ManufacturerDecision
A CUTE BABY, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACUTE IDEAS CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
AMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 2
ANNABELLA LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARDO MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 5
BABYATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
BISTOS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BLUE EGG CO
  SUBSTANTIALLY EQUIVALENT 1
CHIARO TECHNOLOGY LIMITED
  SUBSTANTIALLY EQUIVALENT 2
CIMILRE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CIXI RUIHONG ELECTRIC APPLIANCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DAO HEALTH
  SUBSTANTIALLY EQUIVALENT 3
DEVON MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN RONGFENG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ENKO LTD.
  SUBSTANTIALLY EQUIVALENT 1
EVENFLO COMPANY, INC.
  SUBSTANTIALLY EQUIVALENT 3
EVENFLO FEEDING INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
EVENFLO FEEDING, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXPLORAMED NC7, INC
  SUBSTANTIALLY EQUIVALENT 1
EXPLORAMED NC7, INC.
  SUBSTANTIALLY EQUIVALENT 1
GENADYNE BIOTECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
GLOBALCARE
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG HORIGEN MOTHER & BABY PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG HORIGEN MOTHER & BABY PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
GUANGDONG YOUMENG ELECTRICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU JINXINBAO ELECTRONIC CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU YONGYI INDUSTRIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HAENIM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUIZHOU LVB MATERNAL AND INFANT SUPPLIES CO,LTD.
  SUBSTANTIALLY EQUIVALENT 1
HYGEIA II MEDICAL GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 4
HYGEIA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMANI CO.
  SUBSTANTIALLY EQUIVALENT 3
JOYTECH HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LANSINOH LABORATORIES
  SUBSTANTIALLY EQUIVALENT 2
LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SAN
  SUBSTANTIALLY EQUIVALENT 1
LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SAN. TIC. LTD
  SUBSTANTIALLY EQUIVALENT 1
LIMERICK, INC.
  SUBSTANTIALLY EQUIVALENT 1
LUV N' CARE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MAPA GMBH
  SUBSTANTIALLY EQUIVALENT 2
MAYBORN (UK) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MAYBORN BABY AND CHILD / JACKEL INTERNATIONAL LTD
  SUBSTANTIALLY EQUIVALENT 1
MAYBORN GROUP LIMITED
  SUBSTANTIALLY EQUIVALENT 2
MEDEL S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDELA AG
  SUBSTANTIALLY EQUIVALENT 3
MEDELA LLC
  SUBSTANTIALLY EQUIVALENT 4
MEDELA, INC
  SUBSTANTIALLY EQUIVALENT 1
MILKMATE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MOXXLY, INC.
  SUBSTANTIALLY EQUIVALENT 1
NANTONG POLY TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NAYA HEALTH INC.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO HUIYOO BABY PRODUCTS CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO YOUHE ELECTRICAL APPLIANCE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO YOUHE ELECTRICAL APPLIANCE TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS CONSUMER LIFESTYLE - INNOVATION SITE EINDHOVEN
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS CONSUMER LIFESTYLE-INNOVATION SITE EINDHOVEN
  SUBSTANTIALLY EQUIVALENT 1
SHANTOU HUIHENGQI ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANTOU XINGHE ELECTRICAL APPARATUSES CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN CHANGKUN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN LUTEJIACHENG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN ROOT INNOVATION TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN TPH TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN TPH TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIMPLISSE INC.
  SUBSTANTIALLY EQUIVALENT 1
TOMY INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
UNIMOM CO.
  SUBSTANTIALLY EQUIVALENT 2
UNIMOM.CO
  SUBSTANTIALLY EQUIVALENT 1
UZINMEDICARE CO.
  SUBSTANTIALLY EQUIVALENT 6
UZINMEDICARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
UZINMEDICARE COMPANY
  SUBSTANTIALLY EQUIVALENT 1
WILLOW INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
WUXI XINZHONGRUI BABY SUPPLIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
WUXI XINZHONGRUI BABY SUPPLIES CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
X6 INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG CAREBAO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 1036 1036
2015 496 496
2016 373 373
2017 437 437
2018 291 291
2019 168 168
2020 168 168
2021 119 119
2022 154 154
2023 200 200
2024 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
Decrease in Suction 694 694
Break 508 508
Suction Problem 352 352
Crack 278 278
Fluid/Blood Leak 169 169
Patient Device Interaction Problem 164 164
Device Operates Differently Than Expected 150 150
Failure to Power Up 127 127
Scratched Material 120 120
Material Separation 119 119
Adverse Event Without Identified Device or Use Problem 118 118
Protective Measures Problem 109 109
Insufficient Information 105 105
Noise, Audible 100 100
Sparking 93 93
Component Falling 83 83
Detachment Of Device Component 68 68
Smoking 54 54
Inadequacy of Device Shape and/or Size 50 50
Loose or Intermittent Connection 40 40
Patient-Device Incompatibility 34 34
Power Problem 33 33
Fitting Problem 32 32
Device Slipped 31 31
Overheating of Device 30 30
Melted 29 29
Fire 27 27
Increase in Suction 27 27
Split 26 26
Suction Failure 26 26
Material Integrity Problem 24 24
Nonstandard Device 22 22
Loss of Power 20 20
Improper or Incorrect Procedure or Method 20 20
Device Inoperable 19 19
Inappropriate/Inadequate Shock/Stimulation 17 17
Fail-Safe Problem 17 17
Structural Problem 16 16
Pumping Problem 16 16
Mechanical Problem 15 15
Device Emits Odor 14 14
Unexpected Shutdown 14 14
Output Problem 13 13
Defective Component 13 13
Material Protrusion/Extrusion 11 11
Product Quality Problem 11 11
Contamination 11 11
Complete Blockage 10 10
Failure to Charge 10 10
Device Unsafe to Use in Environment 10 10
Battery Problem 10 10
Charging Problem 10 10
Malposition of Device 10 10
Detachment of Device or Device Component 10 10
Component Missing 10 10
Defective Device 9 9
Obstruction of Flow 9 9
Device Displays Incorrect Message 9 9
Electrical /Electronic Property Problem 9 9
Therapeutic or Diagnostic Output Failure 9 9
Appropriate Term/Code Not Available 8 8
Gas/Air Leak 8 8
Mechanics Altered 7 7
Use of Device Problem 7 7
Failure to Pump 7 7
Hole In Material 7 7
Temperature Problem 7 7
Air Leak 6 6
Premature Discharge of Battery 6 6
Sticking 6 6
Microbial Contamination of Device 6 6
Moisture or Humidity Problem 5 5
Output below Specifications 5 5
Device Reprocessing Problem 5 5
Fail-Safe Design Failure 5 5
Moisture Damage 5 5
Material Fragmentation 4 4
Material Frayed 4 4
Unintended Collision 4 4
Thermal Decomposition of Device 4 4
Device Dislodged or Dislocated 4 4
Failure to Shut Off 3 3
Device Contamination With Biological Material 3 3
Connection Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Vibration 3 3
Self-Activation or Keying 3 3
Circuit Failure 3 3
Collapse 3 3
No Display/Image 3 3
Energy Output Problem 3 3
Leak/Splash 3 3
Migration or Expulsion of Device 3 3
Device Handling Problem 3 3
Torn Material 2 2
Pressure Problem 2 2
Key or Button Unresponsive/not Working 2 2
Infusion or Flow Problem 2 2
Intermittent Loss of Power 2 2
Occlusion Within Device 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1089 1089
Unspecified Infection 901 901
No Information 418 418
Inflammation 365 365
Pain 181 181
Breast Discomfort/Pain 171 171
Bacterial Infection 108 108
Fungal Infection 59 59
No Code Available 52 52
Swelling 41 41
Insufficient Information 32 32
No Clinical Signs, Symptoms or Conditions 29 29
Burn(s) 27 27
No Consequences Or Impact To Patient 27 27
Obstruction/Occlusion 26 26
Rash 21 21
Abscess 19 19
Electric Shock 19 19
Complaint, Ill-Defined 19 19
Erythema 18 18
Injury 15 15
Reaction 13 13
Fever 13 13
Hemorrhage/Bleeding 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Occlusion 12 12
Hypersensitivity/Allergic reaction 10 10
Laceration(s) 10 10
Skin Tears 10 10
Skin Irritation 9 9
Bruise/Contusion 9 9
Irritation 8 8
Tissue Damage 8 8
Skin Infection 7 7
Superficial (First Degree) Burn 6 6
No Patient Involvement 5 5
Burn, Thermal 5 5
Skin Inflammation 5 5
Itching Sensation 5 5
Unspecified Reproductive System or Breast Problem 5 5
Unspecified Tissue Injury 4 4
Sepsis 4 4
Nipple Ulceration 4 4
Blood Loss 4 4
Discomfort 4 4
Nipple Sensation Changes 4 4
Tissue Breakdown 3 3
Alteration In Body Temperature 3 3
Deformity/ Disfigurement 3 3
Skin Discoloration 3 3
Fungus 3 3
Feeding Problem 3 3
Swelling/ Edema 3 3
Blister 3 3
Purulent Discharge 2 2
Swollen Glands 2 2
Chills 2 2
Urticaria 2 2
Anxiety 1 1
Malaise 1 1
Perforation of Vessels 1 1
Burning Sensation 1 1
Misdiagnosis 1 1
Rupture 1 1
Therapeutic Response, Decreased 1 1
Ulcer 1 1
Depression 1 1
Ambulation Difficulties 1 1
Patient Problem/Medical Problem 1 1
Weight Changes 1 1
Intermenstrual Bleeding 1 1
Tachycardia 1 1
Therapeutic Effects, Unexpected 1 1
Thrombus 1 1
Shock 1 1
Hepatitis 1 1
Staphylococcus Aureus 1 1
Scar Tissue 1 1
Increased Sensitivity 1 1
Emotional Changes 1 1
Eructate 1 1
Calcium Deposits/Calcification 1 1
Cyst(s) 1 1
Abrasion 1 1
Hearing Impairment 1 1
Shock from Patient Lead(s) 1 1
Missing Value Reason 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Kidney Infection 1 1
Skin Inflammation/ Irritation 1 1
Contact Dermatitis 1 1
Eczema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AMEDA, INC. III Feb-15-2018
2 Energizer Personal Care II Apr-04-2014
3 Medela Inc III Feb-11-2011
4 Medela Inc II Sep-24-2010
5 Medela Inc II Apr-27-2010
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