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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ELECTRONICS UK LIMITED PHILIPS AVENT DOUBLE ELECTRIC BREAST PUMP

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PHILIPS ELECTRONICS UK LIMITED PHILIPS AVENT DOUBLE ELECTRIC BREAST PUMP Back to Search Results
Model Number SCF 334/02
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Skin Tears (2516)
Event Date 04/22/2015
Event Type  Injury  
Event Description
On (b)(6) 2015 customer claims that the funnels on the pump bodies are too small and are causing bleeding.Consumer stated she discovered a sharp edge to the plastic which caused a small cut on the ridge of her nipple.
 
Manufacturer Narrative
On 04/23/2015 product will be requested to be returned for eval.
 
Manufacturer Narrative
Additional information: on 05/22/2015 product was received for evaluation.
 
Manufacturer Narrative
Additional information: on 11/11/2015 "device works within spec.No visual damage was detected.No sharp edges were observed.Deep in the funnel there is an edge however in normal use (when applying the cushions as instructed in the dru), nipple will not get into contact with the ridge.The user did not follow instructions given in dfu".
 
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Brand Name
PHILIPS AVENT DOUBLE ELECTRIC BREAST PUMP
Type of Device
ELECTRIC BREAST PUMP
Manufacturer (Section D)
PHILIPS ELECTRONICS UK LIMITED
glemsford
UK 
Manufacturer Contact
mary ferreira
1600 summer st.
stamford, CT 06905
2033515949
MDR Report Key4740225
MDR Text Key18926406
Report Number8021997-2015-00003
Device Sequence Number1
Product Code HGX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative,company representative
Reporter Occupation Not Applicable
Type of Report Initial,Followup,Followup
Report Date 04/27/2015
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 Lay User/Patient
Device Model NumberSCF 334/02
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/28/2015
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received05/22/2015
11/16/2015
Was Device Evaluated by Manufacturer? Yes
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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