Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ELECTRONICS UK LTD. PHILIPS AVENT COMFORT MANUAL BREAST PUMP
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHILIPS ELECTRONICS UK LTD. PHILIPS AVENT COMFORT MANUAL BREAST PUMP Back to Search Results
Model Number SCF330/20
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Bacterial Infection (1735)
Event Date 06/02/2015
Event Type  Injury  
Manufacturer Narrative
On (b)(6) 2015 product was requested for evaluation.
 
Event Description
On (b)(6) 2015 consumer claims after using the breast pump for 9 weeks, it has been extremely painful and developed mastitis.She has had several doctors appointments.Consumer feels breast pump does not work well for large breasted women.The cushion that comes with the breast pump is too small and has cut her nipple which over time created a breast infection.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PHILIPS AVENT COMFORT MANUAL BREAST PUMP
Type of Device
MANUAL BREAST PUMP
Manufacturer (Section D)
PHILIPS ELECTRONICS UK LTD.
glemsford
UK 
Manufacturer Contact
mary smith ferreira
1600 summer st.
stamford, CT 06905
2033515949
MDR Report Key5971439
MDR Text Key55572687
Report Number8021997-2015-00006
Device Sequence Number1
Product Code HGY
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K101538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 06/22/2015
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 NumberSCF330/20
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/22/2015
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 N
Patient Sequence Number1
Patient Outcome(s) Other;
-
-