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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
AMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 2
ANNABELLA LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANNABELLA TECH
  SUBSTANTIALLY EQUIVALENT 1
AOJ HEALTH TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARDO MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 2
BISTOS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHIARO TECHNOLOGY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
CHIARO TECHNOLOGY LTD
  SUBSTANTIALLY EQUIVALENT 1
CIMILRE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CIXI RUIHONG ELECTRIC APPLIANCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN RONGFENG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUANSHI YIYINGMEI TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EVENFLO FEEDING, INC.
  SUBSTANTIALLY EQUIVALENT 1
FIMILLA (SHANGHAI) MATERNITY & BABY ARTICLES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG HORIGEN MOTHER & BABY PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG HORIGEN MOTHER & BABY PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GUANGDONG YOUMENG ELECTRICAL TECHNOLOGY 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
HUIZHOU LVB MATERNAL AND INFANT SUPPLIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HYGEIA II MEDICAL GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 3
IMANI CO.
  SUBSTANTIALLY EQUIVALENT 3
JIANGXI AOV MATERNITY & BABY PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JOYTECH HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LANSINOH LABORATORIES
  SUBSTANTIALLY EQUIVALENT 2
MAYBORN (UK) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDELA LLC
  SUBSTANTIALLY EQUIVALENT 3
MILKMATE PRODUCTS INC.
  SUBSTANTIALLY EQUIVALENT 1
MILKMATE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO DEAREVERY ELECTRONIC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NINGBO HUIYOO BABY PRODUCTS CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO YOUHE ELECTRICAL APPLIANCE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS CONSUMER LIFESTYLE - INNOVATION SITE EINDHOVEN
  SUBSTANTIALLY EQUIVALENT 2
SHANTOU HUIHENGQI ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CHANGKUN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN LUTEJIACHENG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN ROOT INNOVATION TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN TPH TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
SHENZHEN TPH TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ROOT INNOVATION TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
UNIMOM.CO
  SUBSTANTIALLY EQUIVALENT 1
UZINMEDICARE CO.
  SUBSTANTIALLY EQUIVALENT 2
UZINMEDICARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WILLOW INNOVATIONS, INC.
  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
2020 168 168
2021 119 119
2022 154 154
2023 200 200
2024 118 118

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 215 215
Decrease in Suction 143 143
Suction Problem 110 110
Adverse Event Without Identified Device or Use Problem 57 57
Power Problem 29 29
Failure to Power Up 22 22
Insufficient Information 20 20
Noise, Audible 14 14
Unexpected Shutdown 13 13
Melted 12 12
Suction Failure 12 12
Inadequacy of Device Shape and/or Size 10 10
Break 10 10
Therapeutic or Diagnostic Output Failure 9 9
Output Problem 9 9
Overheating of Device 8 8
Fire 7 7
Obstruction of Flow 7 7
Charging Problem 6 6
Product Quality Problem 6 6
Defective Device 5 5
Fitting Problem 5 5
Pumping Problem 4 4
Patient-Device Incompatibility 4 4
Defective Component 4 4
Mechanical Problem 4 4
Loose or Intermittent Connection 4 4
Increase in Suction 4 4
Energy Output Problem 3 3
Device Displays Incorrect Message 3 3
Improper or Incorrect Procedure or Method 3 3
Sparking 3 3
Moisture or Humidity Problem 3 3
Vibration 2 2
Moisture Damage 2 2
Premature Discharge of Battery 2 2
Key or Button Unresponsive/not Working 2 2
No Display/Image 2 2
Connection Problem 2 2
Pressure Problem 2 2
Fluid/Blood Leak 2 2
Detachment of Device or Device Component 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Loss of or Failure to Bond 1 1
Loss of Power 1 1
Electrical /Electronic Property Problem 1 1
Display or Visual Feedback Problem 1 1
Human-Device Interface Problem 1 1
Nonstandard Device 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 228 228
Breast Discomfort/Pain 221 221
Inflammation 115 115
Bacterial Infection 37 37
No Clinical Signs, Symptoms or Conditions 33 33
Insufficient Information 33 33
Pain 24 24
No Known Impact Or Consequence To Patient 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Skin Infection 7 7
Skin Tears 6 6
Obstruction/Occlusion 6 6
Unspecified Reproductive System or Breast Problem 5 5
Superficial (First Degree) Burn 5 5
No Code Available 5 5
Burn(s) 5 5
Rash 5 5
Unspecified Tissue Injury 4 4
Abscess 4 4
Laceration(s) 4 4
Swelling 4 4
Fever 4 4
Blister 3 3
Burn, Thermal 3 3
Fungal Infection 3 3
Swelling/ Edema 3 3
Sepsis 3 3
Skin Irritation 3 3
Injury 2 2
Blood Loss 2 2
No Consequences Or Impact To Patient 2 2
Hemorrhage/Bleeding 2 2
Tissue Breakdown 2 2
Bruise/Contusion 2 2
Burning Sensation 1 1
Chills 1 1
Hepatitis 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Abrasion 1 1
Discomfort 1 1
Depression 1 1
No Patient Involvement 1 1
Skin Inflammation/ Irritation 1 1
Nipple Ulceration 1 1
Perforation of Vessels 1 1
Contact Dermatitis 1 1
Calcium Deposits/Calcification 1 1
Eczema 1 1
Hypersensitivity/Allergic reaction 1 1
Kidney Infection 1 1

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