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

Model Number SCF332

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 03/28/2017

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 customer claims to have received an inflammation after using the breast pump.The inflammation was small and internal, and has been remedied through antibiotics.The customer may no longer use breast pumps (including the one used in the hospital) because of the high intake dosage of vitamin d.The customer does not believe the breast pump was the cause of the inflammation.

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.Supplemental 1: the device was received from the consumer and tested by the manufacturer.Results concluded the device to be working in accordance to specification.

Event Description

The customer claims to have received an inflammation after using the breast pump.The inflammation was small and internal, and has been remedied through antibiotics.The customer may no longer use breast pumps (including the one used in the hospital) because of the high intake dosage of vitamin d.The customer does not believe the breast pump was the cause of the inflammation.

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.The device was received from the consumer and tested by the manufacturer.Results concluded the device to be working in accordance to specification.Updated the 510(k) information.

Event Description

The customer claims to have received an inflammation after using the breast pump.The inflammation was small and internal, and has been remedied through antibiotics.The customer may no longer use breast pumps (including the one used in the hospital) because of the high intake dosage of vitamin d.The customer does not believe the breast pump was the cause of the inflammation.

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.Supplemental 1: the device was received from the consumer and tested by the manufacturer.Results concluded the device to be working in accordance to specification.Supplemental 2: updated the 510(k) information.(b)(6) 2019 - supplemental 3 updated fields d4, e1, g4, h2, h3, h4, h5 and h6.

Event Description

The customer claims to have received an inflammation after using the breast pump.The inflammation was small and internal, and has been remedied through antibiotics.The customer may no longer use breast pumps (including the one used in the hospital) because of the high intake dosage of vitamin d.The customer does not believe the breast pump was the cause of the inflammation.

• Brand Name: PHILIPS AVENT COMFORT SINGLE ELECTRIC BREAST PUMP
• Type of Device: SINGLE BREAST PUMP
• Manufacturer (Section D): PHILIPS ELECTRONICS UK LIMITED; lower road; glemsford, ; UK
• MDR Report Key: 6529183
• MDR Text Key: 73906312
• Report Number: 8021997-2017-00003
• 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,Followup
• Report Date: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1