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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
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Unspecified Infection (1930); Inflammation (1932)
Event Type  Injury  
Manufacturer Narrative
Device has been requested from consumer for analysis.Use of breast pumps is not known to cause or contribute to this event.Requested, but not returned.
 
Event Description
The consumer spoke about 'mastitis' when explaining an issue with the breast pump cushion.
 
Manufacturer Narrative
Use of breast pumps is not known to have cause of contributed to this event.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.Supplemental report: the consumer returned the device and it tested in accordance to the specifications.No failure was found.
 
Event Description
The consumer spoke about 'mastitis' when explaining an issue with the breast pump cushion.
 
Manufacturer Narrative
Use of breast pumps is not known to have cause of contributed to this event.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.Supplemental report: the consumer returned the device and it tested in accordance to the specifications.No failure was found.
 
Event Description
The consumer spoke about 'mastitis' when explaining an issue with the breast pump cushion.
 
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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,
UK 
Manufacturer (Section G)
PHILIPS ELETRONICS UK
philips electronics uk limited
lower road
glemsford, suffolk co10 7qs, CO10 7QS
UK   CO10 7QS
Manufacturer Contact
nina ruiz
1600 summer st.
stamford, CT 06912
MDR Report Key6188457
MDR Text Key62794432
Report Number8021997-2016-00009
Device Sequence Number1
Product Code HGX
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K161532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 11/24/2016
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? Yes
Device Operator No Information
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/24/2016
Initial Date FDA Received12/20/2016
Supplement Dates Manufacturer Received11/24/2016
11/24/2016
Supplement Dates FDA Received09/11/2017
05/07/2018
Was Device Evaluated by Manufacturer? Yes
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;
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