MAUDE Adverse Event Report: PAYER INDUSTRIES HUNGARY PHILIPS AVENT MANUAL BREAST PUMP; BREAST PUMP NOT-POWERED

Model Number	SCF430/01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Breast Discomfort/Pain (4504)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer claims that the manual breast pump caused mastitis.
Additional Manufacturer Narrative
December 2nd 2025 update: the device was returned and tested.It was found working according to specifications.The customer reports using the manual breast pump approximately 10 times for sessions of about 15 minutes, as she otherwise breastfeeds almost exclusively.She applies the pump by placing the breast into it.During use, she experienced a sharp pulling pain in the nipple, and after a pumping session developed a very sore, red area on the breast with a painful lump.She was diagnosed with mastitis by her doctor.The nipple also developed a bleb.Bleb formation can be attributable to the user placing her breast in pump, while the instruction for use recommends to press the pump against the breast.Placing the breast in the pump can cause that the expression kit is not centered in the nipple.This could lead to temporary discomfort (such as nipple blebs); it is unlikely that this scenario leads to mastitis within such a short time frame (right after a pumping session in this case).Customer is exclusively breastfeeding.Mastitis is a common condition among breastfeeding mothers, with a prevalence of up to 30%.
Event or Problem Description
Customer claims that the manual breast pump caused mastitis.The device has been tested and been found performing according to specifications.No anomalies have been detected on the device.

• Brand Name: PHILIPS AVENT MANUAL BREAST PUMP
• Common Device Name: BREAST PUMP NOT-POWERED
• Manufacturer (Section D): PAYER INDUSTRIES HUNGARY; sport street 27.; ajka veszprem HU 8 400; HU HU 8400
• Manufacturer (Section G): PAYER INDUSTRIES HUNGARY; sport street 27.; ajka veszprem HU 8 400; HU HU 8400
• Manufacturer Contact: shaylee masilunas ; 1600 summer street; stamford, CT 06905 ; 2039730200
• MDR Report Key: 22920702
• Report Number: 3010359222-2025-000003
• Device Sequence Number: 13319703
• Product Code: HGY
• UDI-Device Identifier: 00075020109453
• UDI-Public: 00075020109453
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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
• Operator of Device: Other
• Device Model Number: SCF430/01
• Device Catalogue Number: SCF430/01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown