Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
ARDO MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 2
BISTOS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHIARO TECHNOLOGY LIMITED
  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
EVENFLO FEEDING, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXPLORAMED NC7, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG HORIGEN MOTHER & BABY PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG HORIGEN MOTHER & BABY PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
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
HYGEIA II MEDICAL GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 4
IMANI CO.
  SUBSTANTIALLY EQUIVALENT 3
JIANGXI AOV MATERNITY & BABY PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LANSINOH LABORATORIES
  SUBSTANTIALLY EQUIVALENT 2
LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SAN. TIC. LTD
  SUBSTANTIALLY EQUIVALENT 1
MAYBORN (UK) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDELA AG
  SUBSTANTIALLY EQUIVALENT 1
MEDELA LLC
  SUBSTANTIALLY EQUIVALENT 3
MILKMATE PRODUCTS, INC.
  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 1
SHENZHEN TPH TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN TPH TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
UNIMOM CO.
  SUBSTANTIALLY EQUIVALENT 1
UNIMOM.CO
  SUBSTANTIALLY EQUIVALENT 1
UZINMEDICARE CO.
  SUBSTANTIALLY EQUIVALENT 3
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
2019 168 168
2020 168 168
2021 119 119
2022 154 154
2023 200 200
2024 53 53

Device Problems MDRs with this Device Problem Events in those MDRs
Decrease in Suction 192 192
Patient Device Interaction Problem 172 172
Suction Problem 124 124
Adverse Event Without Identified Device or Use Problem 72 72
Noise, Audible 31 31
Failure to Power Up 28 28
Power Problem 26 26
Suction Failure 23 23
Insufficient Information 21 21
Inadequacy of Device Shape and/or Size 15 15
Unexpected Shutdown 13 13
Break 12 12
Melted 12 12
Output Problem 11 11
Fluid/Blood Leak 10 10
Smoking 9 9
Therapeutic or Diagnostic Output Failure 9 9
Fire 9 9
Defective Component 8 8
Defective Device 8 8
Overheating of Device 8 8
Fitting Problem 8 8
Product Quality Problem 7 7
Patient-Device Incompatibility 7 7
Increase in Suction 7 7
Obstruction of Flow 7 7
Sparking 6 6
Charging Problem 6 6
Pumping Problem 5 5
Mechanical Problem 5 5
Loose or Intermittent Connection 4 4
Improper or Incorrect Procedure or Method 4 4
Battery Problem 3 3
Energy Output Problem 3 3
No Display/Image 3 3
Device Displays Incorrect Message 3 3
Premature Discharge of Battery 3 3
Moisture or Humidity Problem 3 3
Detachment of Device or Device Component 3 3
Device Emits Odor 3 3
Loss of Power 2 2
Pressure Problem 2 2
Failure to Shut Off 2 2
Display or Visual Feedback Problem 2 2
Increased Pump Speed 2 2
Moisture Damage 2 2
Connection Problem 2 2
Key or Button Unresponsive/not Working 2 2
Component Missing 2 2
Appropriate Term/Code Not Available 2 2
Vibration 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Gas/Air Leak 2 2
Infusion or Flow Problem 1 1
Unintended Electrical Shock 1 1
Human-Device Interface Problem 1 1
Flare or Flash 1 1
Contamination 1 1
Failure to Deliver 1 1
Structural Problem 1 1
Material Puncture/Hole 1 1
Failure to Charge 1 1
Material Split, Cut or Torn 1 1
Loss of or Failure to Bond 1 1
Component Misassembled 1 1
Delivered as Unsterile Product 1 1
Circuit Failure 1 1
Backflow 1 1
Electrical /Electronic Property Problem 1 1
Sharp Edges 1 1
Fungus in Device Environment 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Computer Software Problem 1 1
Device Alarm System 1 1
No Device Output 1 1
Packaging Problem 1 1
Microbial Contamination of Device 1 1
Crack 1 1
Nonstandard Device 1 1
Leak/Splash 1 1
Unintended Collision 1 1
Material Separation 1 1
Fumes or Vapors 1 1
Protective Measures Problem 1 1
Unclear Information 1 1
Intermittent Loss of Power 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 298 298
Breast Discomfort/Pain 180 180
Inflammation 120 120
No Known Impact Or Consequence To Patient 53 53
Pain 50 50
Insufficient Information 32 32
Bacterial Infection 31 31
No Clinical Signs, Symptoms or Conditions 29 29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
No Code Available 9 9
Swelling 8 8
Burn(s) 7 7
Fungal Infection 7 7
Obstruction/Occlusion 7 7
Skin Tears 7 7
Skin Infection 7 7
Superficial (First Degree) Burn 6 6
Fever 6 6
Hemorrhage/Bleeding 6 6
Rash 6 6
No Consequences Or Impact To Patient 6 6
Abscess 5 5
Laceration(s) 5 5
Burn, Thermal 5 5
Unspecified Reproductive System or Breast Problem 5 5
Unspecified Tissue Injury 4 4
Bruise/Contusion 4 4
Skin Irritation 4 4
Sepsis 4 4
Swelling/ Edema 3 3
Blister 3 3
No Information 3 3
Reaction 2 2
Tissue Breakdown 2 2
Blood Loss 2 2
Tissue Damage 2 2
Chills 2 2
Injury 2 2
Erythema 2 2
Irritation 2 2
Itching Sensation 1 1
Calcium Deposits/Calcification 1 1
Eructate 1 1
Abrasion 1 1
Hepatitis 1 1
Hypersensitivity/Allergic reaction 1 1
Depression 1 1
Urticaria 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Perforation of Vessels 1 1
Burning Sensation 1 1
Tachycardia 1 1
Skin Discoloration 1 1
Weight Changes 1 1
No Patient Involvement 1 1
Electric Shock 1 1
Nipple Ulceration 1 1
Skin Inflammation 1 1
Alteration In Body Temperature 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

-
-