MAUDE Adverse Event Report: MEDELA AG FREESTYLE BREASTPUMP; PUMP, BREAST, POWERED

Model Number	27260
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	02/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medela llc customer service referred the customer to medela (b)(4) customer service.On 02/11/2020, medela (b)(4) customer service contacted the customer and she indicated that she was using a 24mm breast shield on one side and a 27mm breast shield on the other side, as recommended by her lactation consultant.Additionally, she indicated that she cleaned her kit parts with warm soapy water, but had never sanitized them.She stated that she had been able to use a medela symphony breast pump upon birth successfully and her baby was taking the breast well, but while pumping with the freestyle breast pump for 20 minutes she had only expressed 15ml combined.She also indicated she had seen a doctor because of the pain from pumping and had been prescribed a cream.Medela (b)(4) customer service conducted troubleshooting with the customer, including disassembling, inspecting, cleaning and reassembling the kit and tubing set; and verifying breast shield fit.The troubleshooting did not resolve the issue.The customer was sent a replacement pump, a breast shield sizer, and a one month access code for the medela 24/7 lc breastfeeding support application.Return of her original pump was requested for testing/evaluation.The customer was contacted by a complaint handler on multiple occasions, including in writing, to get additional information, with no response as of the date of this report.Medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed).
Event or Problem Description
On 02/07/2020, the customer alleged to medela llc that her freestyle breast pump had low suction and her nipples were burning after pumping, due to not being able to pump.

• Brand Name: FREESTYLE BREASTPUMP
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ 6341
• MDR Report Key: 9793539
• Report Number: 1419937-2020-00018
• Device Sequence Number: 14077468
• Product Code: HGX
• UDI-Device Identifier: 00020451330921
• UDI-Public: 020451330921
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K150499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: Lay User/Patient
• Device Model Number: 27260
• Device Catalogue Number: 27260
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 03/05/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other