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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ELECTRONICS UK LIMITED PHILIPS AVENT MANUAL BREAST PUMP
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PHILIPS ELECTRONICS UK LIMITED PHILIPS AVENT MANUAL BREAST PUMP Back to Search Results
Model Number SCF330
Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 01/08/2018
Event Type  Injury  
Manufacturer Narrative
The device has been designed according to safety standards and is safe to use when used according to the dfu.Device has been requested for analysis.
 
Event Description
Consumer stated that she was using the device per the manual and the device stopped to make a vacuum.She claims that due to this she became ill with lactostasis.She stated that this illness included fever and redness.
 
Manufacturer Narrative
The device has been designed according to safety standards and is safe to use when used according to the dfu.Device has been requested for analysis.Follow-up 1 04/18/2018- device returned for analysis.Based on the analysis of the returned device, the devices is operating according to specification.Mastitis is a secondary complication of an expected side effect and is, therefore, not considered to be caused by the breast pump.
 
Event Description
Consumer stated that she was using the device per the manual and the device stopped to make a vacuum.She claims that due to this she became ill with lactostasis.She stated that this illness included fever and redness.
 
Manufacturer Narrative
The device has been designed according to safety standards and is safe to use when used according to the dfu.Device has been requested for analysis.Follow-up 1 04/18/2018- device returned for analysis.Based on the anaylsis of the returned device, the devices is operating according to specification.Mastitis is a secondary complication of an expected side effect and is, therefore, not considered to be caused by the breast pump.Corrected 07/08/2019- date received by manufacturer (field g4) was not updated per the previous supplemental.Follow up date received by manufacturer corrected to april 11, 2018.
 
Event Description
Consumer stated that she was using the device per the manual and the device stopped to make a vacuum.She claims that due to this she became ill with lactostasis.She stated that this illness included fever and redness.
 
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Brand Name
PHILIPS AVENT MANUAL BREAST PUMP
Type of Device
MANUAL BREAST PUMP
Manufacturer (Section D)
PHILIPS ELECTRONICS UK LIMITED
lower road
glemsford, CO10 7QS
UK  CO10 7QS
MDR Report Key7232349
MDR Text Key98711004
Report Number8021997-2018-00001
Device Sequence Number1
Product Code HGY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup,Followup
Report Date 01/15/2018
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 No Information
Device Model NumberSCF330
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2018
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/15/2018
Initial Date FDA Received01/31/2018
Supplement Dates Manufacturer Received01/15/2018
04/11/2018
Supplement Dates FDA Received04/18/2018
07/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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