MAUDE Adverse Event Report: PHILIPS ELECTRONICS UK LIMITED PHILIPS AVENT COMFORT MANUAL BREAST PUMP

Model Number SCF330/20

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bacterial Infection (1735)

Event Date 07/17/2015

Event Type  Injury  

Event Description

On 07/17/2015 consumer claims after using the breast pump and it became 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.

• Brand Name: PHILIPS AVENT COMFORT MANUAL BREAST PUMP
• Type of Device: MANUAL BREAST PUMP
• Manufacturer (Section D): PHILIPS ELECTRONICS UK LIMITED; glemsford ; UK
• Manufacturer Contact: mary smith ferreira ; 1600 summer st; stamford, CT 06905 ; 2033515949
• MDR Report Key: 4995467
• MDR Text Key: 23084866
• Report Number: 8021997-2015-00007
• Device Sequence Number: 1
• Product Code: HGY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K101538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Not Applicable
• Report Date: 07/22/2015

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 Number: SCF330/20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2015
• 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 Number: 1
• Patient Outcome(s): Other