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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 Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
Use of breast pumps is not known to have cause of contributed to this event.Bleeding is a known side effect of breast feeding and using breast pumps.The device has been designed according to safety standards and is safe when used in according to the dfu.The device has been requested from the consumer for analysis.
 
Event Description
The customer claims that she bought the device and noticed that the cushion size was too big for her.She replaced the cushion with a smaller size thinking that it would work, but it did not.She has three open sores on her breast, has had previous infections, and is worried that she is going to get another infection or something worse because she can't pump.Her son is only (b)(6) old, she has been using the device for only a month now, and it has occurred six times already.
 
Manufacturer Narrative
Use of breast pumps is not known to have cause of contributed to this event.Bleeding is a known side effect of breast feeding and using breast pumps.The device has been designed according to safety standards and is safe when used in according to the dfu.The device has been requested from the consumer for analysis.New information 9/26/2017: the device was returned from the consumer and tested in accordance to specifications.
 
Event Description
The customer claims that she bought the device and noticed that the cushion size was too big for her.She replaced the cushion with a smaller size thinking that it would work, but it did not.She has three open sores on her breast, has had previous infections, and is worried that she is going to get another infection or something worse because she can't pump.Her son is only (b)(6) months old, she has been using the device for only a month now, and it has occurred six times already.
 
Event Description
The customer claims that she bought the device and noticed that the cushion size was too big for her.She replaced the cushion with a smaller size thinking that it would work, but it did not.She has three open sores on her breast, has had previous infections, and is worried that she is going to get another infection or something worse because she can't pump.Her son is only two months old, she has been using the device for only a month now, and it has occurred six times already.
 
Manufacturer Narrative
Use of breast pumps is not known to have cause of contributed to this event.Bleeding is a known side effect of breast feeding and using breast pumps.The device has been designed according to safety standards and is safe when used in according to the dfu.The device has been requested from the consumer for analysis.26sept2017 (supplemental 1).The device was returned from the consumer and tested in accordance to specifications.14aug2019 (supplemental 2).
 
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Brand Name
PHILIPS AVENT COMFORT DOUBLE ELECTRIC BREAST PUMP
Type of Device
DOUBLE ELECTRIC BREAST PUMP
Manufacturer (Section D)
PHILIPS ELECTRONICS UK LIMITED
lower road
glemsford,
UK 
MDR Report Key6750795
MDR Text Key81290883
Report Number8021997-2017-00005
Device Sequence Number1
Product Code HGX
Combination Product (y/n)N
PMA/PMN Number
K161532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup
Report Date 07/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2017
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 Manufacturer08/14/2017
Was the Report Sent to FDA? No
Date Manufacturer Received09/12/2017
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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