MAUDE Adverse Event Report: PHILIPS CONSUMER LIFESTYLE B.V. PHILIPS AVENT COMFORT MANUAL BREAST PUMP

Model Number SCF330/30

Device Problem Insufficient Information (3190)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

The manufacturer is making an effort to retrieve the device for investigation.We are reporting this event because based on the current available information the patient was treated to prevent potential serious injury.

Event Description

Breast pump caused a red mark on skin.The user sought medical attention and was prescribed antibiotics.

Manufacturer Narrative

The manufacturer is making an effort to retrieve the device for investigation.We are reporting this event because based on the current available information the patient was treated to prevent potential serious injury.Update 11/23/2021: the device was returned to philips for investigation.The device performance was within specifications.No anomaly was detected.Based on the information provided by the consumer, it is not clear whether the consumer suffered from mastitis.Mastitis is a secondary complication of known side effects of using a breast pump and of breastfeeding.Pain, bruising, nipple trauma, thrombus, rash are known side effects of natural breast feeding and also known side effects of using breast pumps.We know that a slight change of the position during using of the device may help to avoid pain as well as a larger cushion can help.The device has been designed according to safety standards and is safe to use when used according to the dfu.Philips continues to monitor this type of events as part of the post market surveillance process activities.

Event Description

Breast pump caused a red mark on skin.The user sought medical attention and was prescribed antibiotics.

• Brand Name: PHILIPS AVENT COMFORT MANUAL BREAST PUMP
• Type of Device: MANUAL BREAST PUMP
• Manufacturer (Section D): PHILIPS CONSUMER LIFESTYLE B.V.; tussendiepen 4; drachten, 9026A D; NL 9026AD
• Manufacturer Contact: shaylee masilunas ; 1600 summer street; stamford, CT 06902 ; 4125423485
• MDR Report Key: 12584699
• MDR Text Key: 274995493
• Report Number: 3010359222-2021-00004
• Device Sequence Number: 1
• Product Code: HGY
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

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: Lay User/Patient
• Device Model Number: SCF330/30
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 10/06/2021
• Supplement Dates Manufacturer Received: 09/08/2021
• Supplement Dates FDA Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Sex: Female