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

Model Number SCF332

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

According to the consumer the product did not cause the condition.This report is being submitted as a precaution.

Event Description

The consumer stated that she has mastitis and when she tries to use the breast pump the device does not operate continuously.The consumer claims that the device turns off and stops pumping when there is still milk in her breast.

• Brand Name: PHILIPS AVENT SINGLE ELECTRIC BREAST PUMP
• Type of Device: BREAST PUMP
• Manufacturer (Section D): PHILIPS ELECTRONICS UK LIMITED; lower road; glemsford ; UK
• 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: 7139733
• MDR Text Key: 95542157
• Report Number: 8021997-2017-00008
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• PMA/PMN Number: K161532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 11/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SCF332
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other