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

Model Number SCF330

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

Lactostatsis occurs when milk stays still in the breast, not from being removed from the breast.The device has been designed according to safety standards and is safe to use when used according to the dfu.Additional information will be provided if it becomes available.

Event Description

The consumer claimed that she has not been satisfied with the device and has developed lactostasis.

Manufacturer Narrative

Lactostatsis occurs when milk stays still in the breast, not from being removed from the breast.The device has been designed according to safety standards and is safe to use when used according to the dfu.Additional information will be provided if it becomes available.Update october 12, 2018.The device is not available for investigation.Lactostatsis occurs when milk stays still in the breast, not from being removed from the breast.It can cause pain and discomfort(from engorgement), but also can grow bacteria and cause mastitis.Further, mastitis is a secondary complication to an expected side effect and is, therefore, not considered to be caused by the breast pump.The device has been designed according to safety standards and is safe to use when used according to the dfu.

Event Description

The consumer claimed that she has not been satisfied with the device and has developed lactostasis.

Event Description

The consumer claimed that she has not been satisfied with the device and has developed lactostasis.

Manufacturer Narrative

Lactostatsis occurs when milk stays still in the breast, not from being removed from the breast.The device has been designed according to safety standards and is safe to use when used according to the dfu.Additional information will be provided if it becomes available.Update october 12, 2018: the device is not available for investigation.Lactostatsis occurs when milk stays still in the breast, not from being removed from the breast.It can cause pain and discomfort(from engorgement), but also can grow bacteria and cause mastitis.Further, mastitis is a secondary complication to an expected side effect and is, therefore, not considered to be caused by the breast pump.The device has been designed according to safety standards and is safe to use when used according to the dfu.Corrected july 9, 2019: date received by manufacturer (field g4) was not updated per the previous supplmental.Follow up date received by manufacturer corrected to october 12, 2018.

• Brand Name: PHILIPS AVENT COMFORT MANUAL BREAST PUMP
• Type of Device: MANUAL BREAST PUMP
• Manufacturer (Section D): PHILIPS ELECTRONICS UK LIMITED; lower road; glemsford, CO10 7QS; UK CO10 7QS
• MDR Report Key: 7898455
• MDR Text Key: 121033463
• Report Number: 8021997-2018-00004
• Device Sequence Number: 1
• Product Code: HGY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2018

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: SCF330
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2018
• Initial Date FDA Received: 09/21/2018
• Supplement Dates Manufacturer Received: 08/31/2018; 10/12/2018
• Supplement Dates FDA Received: 10/12/2018; 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other