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

Model Number SCF334

Device Problems Use of Device Problem (1670); Device Operates Differently Than Expected (2913)

Patient Problem Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

An inflammation of the breast tissue can occur following clogged mammary ducts being left untreated or as a secondary effect caused by bacteria.Use of breast pumps is not known to cause or contribute to this event.The device has been designed according to safety standards and is safe to use when used according to the dfu.The device has been designed according to safety standards and is safe when used in according to the dfu.The device has been requested from the consumer for analysis.

Event Description

The consumer initially called indicating that her pump had stopped working after a couple of minutes of trying to use the product.Approximately two months later, she called back indicating that developed a breast inspection, mastitis, which she claims made her baby sick.

Manufacturer Narrative

An inflammation of the breast tissue can occur following clogged mammary ducts being left untreated or as a secondary effect caused by bacteria.Use of breast pumps is not known to cause or contribute to this event.The device has been designed according to safety standards and is safe when used in according to the dfu.The device has been requested from the consumer for analysis.Additional information:.The device in question was tested by the manufacturer and was found to be functioning within specifications.No failure was found.

Event Description

The consumer initially called indicating that her pump had stopped working after a couple of minutes of trying to use the product.Approximately two months later, she called back indicating that developed a breast infection, mastitis, which she claims made her baby sick.

Manufacturer Narrative

An inflammation of the breast tissue can occur following clogged mammary ducts being left untreated or as a secondary effect caused by bacteria.Use of breast pumps is not known to cause or contribute to this event.The device has been designed according to safety standards and is safe when used in according to the dfu.The device has been requested from the consumer for analysis.Additional information:.The device in question was tested by the manufacturer and was found to be functioning within specifications.No failure was found.

Event Description

The consumer initally called indicating that her pump had stopped working after a couple of minutes of trying to use the product.Approximately two months later, she called back indicating that developed a breast infection, mastitis, which she claims made her baby sick.

• Brand Name: PHILIPS AVENT COMFORT DOUBLE ELECTRIC BREAST PUMP
• Type of Device: BREAST PUMP
• Manufacturer (Section D): PHILIPS ELECTRONICS UK LIMITED; lower road; glemsford, ; UK
• MDR Report Key: 6749796
• MDR Text Key: 81234698
• Report Number: 8021997-2017-00004
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• 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: 07/24/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1