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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS CONSUMER LIFESTYLE B.V. PHILIPS AVENT MANUAL BREAST PUMP; BREAST PUMP, MANUAL
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PHILIPS CONSUMER LIFESTYLE B.V. PHILIPS AVENT MANUAL BREAST PUMP; BREAST PUMP, MANUAL Back to Search Results
Model Number SCF430/10
Device Problem Insufficient Information (3190)
Patient Problem Breast Discomfort/Pain (4504)
Event Type  Injury  
Event Description
The customer stated that after using the manual breast pump, she had pain in her breast.She also felt congestion in the breast, felt lumps around areola and side of left breast.The customer did not seek medical attention.
 
Manufacturer Narrative
Based on the limited information provided by the customer, we are attempting to retrieve the device for a formal investigation.However we know that pain and bruisees are known side effects of natural breast feeding and also known side effects of using breast pumps.The device has been designed according to safety standards and is safe to use when used according to the dfu.
 
Event Description
The customer stated that after using the manual breast pump, she had pain in her breast.She also felt congestion in the breast, felt lumps around areola and side of left breast.The customer did not seek medical attention.
 
Manufacturer Narrative
Based on the limited information provided by the customer, we are attempting to retrieve the device for a formal investigation.However we know that pain and bruises are known side effects of natural breast feeding and also known side effects of using breast pumps.The device has been designed according to safety standards and is safe to use when used according to the dfu.Follow up #1: the device was returned to philips for investigation and was found to be performing as per specification.No product anomalies were found.Pain and nipple trauma are common side effects of natural breast feeding and also known side effects of using breast pumps.The device has been designed according to safety standards and is safe to use when used according to the dfu.
 
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Brand Name
PHILIPS AVENT MANUAL BREAST PUMP
Type of Device
BREAST PUMP, MANUAL
Manufacturer (Section D)
PHILIPS CONSUMER LIFESTYLE B.V.
tussendiepen 4
drachten, 9026 AD
NL  9026 AD
Manufacturer (Section G)
PAYER INDUSTRIES
sport utca 27
ajka, 8400
HU   8400
Manufacturer Contact
shaylee masilunas
1600 summer street
stamford, CT 06902
8143275198
MDR Report Key14787315
MDR Text Key294580286
Report Number3010359222-2022-00001
Device Sequence Number1
Product Code HGY
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberSCF430/10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/30/2022
Initial Date FDA Received06/23/2022
Supplement Dates Manufacturer Received05/30/2022
Supplement Dates FDA Received10/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
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