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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ELECTRONICS UK LIMITED PHILIPS AVENT COMFORT DOUBLE ELECTRIC BREAST PUMP
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PHILIPS ELECTRONICS UK LIMITED PHILIPS AVENT COMFORT DOUBLE ELECTRIC BREAST PUMP Back to Search Results
Model Number SCF334
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
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.Efforts are being made to retrieve the device from the consumer.
 
Event Description
The consumer stated that they used the product without the massage cushion for about two months while also breastfeeding.She noted that she experienced pain while pumping.The consumer claimed that in the last month pumping started to hurt a lot more and the skin around the nipples started to break down and wounds occurred.The consumer continued to use the pump because she needed to pump.The consumer went to the doctor due to the wounds.She used an ointment initially, but it did not heal the wounds.The consumer then got a breast infection in one breast.She received antibiotics for this infection and is in contact with a lactation expert.
 
Manufacturer Narrative
The device has been designed according to safety standards and is safe to use when used according to the dfu.Efforts are being made to retrieve the device from the consumer.(b)(6) 2019 the device was retrieved from the consumer.The device was tested and found to be working according to specification.Mastitis is a secondary complication to an expected side effect and is, therefore, not considered to be caused by the breast pump.We will continue monitoring these events in post market surveillance.
 
Event Description
The consumer stated that they used the product without the massage cushion for about two months while also breastfeeding.She noted that she experienced pain while pumping.The consumer claimed that in the last month pumping started to hurt a lot more and the skin around the nipples started to break down and wounds occurred.The consumer continued to use the pump because she needed to pump.The consumer went to the doctor due to the wounds.She used an ointment initially, but it did not heal the wounds.The consumer then got a breast infection in one breast.She received antibiotics for this infection and is in contact with a lactation expert.
 
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Brand Name
PHILIPS AVENT COMFORT DOUBLE ELECTRIC BREAST PUMP
Type of Device
ELECTRIC BREAST PUMP
Manufacturer (Section D)
PHILIPS ELECTRONICS UK LIMITED
lower road
glemsford, CO10 7QS
UK  CO10 7QS
MDR Report Key8866707
MDR Text Key153449435
Report Number8021997-2019-00002
Device Sequence Number1
Product Code HGX
Combination Product (y/n)N
PMA/PMN Number
K051413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 07/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberSCF334
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/30/2019
Date Manufacturer Received09/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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