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

Model Number SCF334

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Inflammation (1932)

Event Date 03/21/2018

Event Type  Injury  

Manufacturer Narrative

Mastitis is a secondary complication to an expected side effect and is, therefore, not considered to be caused by the breast pump.It is a known rare complication of breastfeeding.Based on the evaluation of this product, this product performs according to specification.

Event Description

Consumer initially stated that the device did not operate according to her expectations.The consumer, two months later, communicated that she was diagnosed with mastitis for an unknown reason.The consumer claims that her doctor stated her mastitis could have been due to anything including: infection due to nipple damage, excessive suction effect of pump, incomplete emptying of breast due to inefficient pumping and/or sucking.

• 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, suffolk CO10 7QS; UK CO10 7QS
• Manufacturer (Section G): PHILIPS ELECTRONICS UK LIMITED; lower road; glemsford, suffolk CO10 7QS; UK CO10 7QS
• Manufacturer Contact: nina ruiz ; 1600 summer street; stamford, CT 06912
• MDR Report Key: 7401330
• MDR Text Key: 104527298
• Report Number: 8021997-2018-00002
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K161532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2018

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: SCF334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/05/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other