MAUDE Adverse Event Report: MEDELA AG FREESTYLE W TOTE PT-A 1CT EN; PUMP, BREAST, POWERED

Model Number	101034712
Health Effect - Clinical Code	Abscess (1690)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer service sent the customer a pump in style breast pump as a replacement and return of her original device was requested for testing/evaluation.In follow up with a complaint handler on 05/26/2020, the customer indicated that she developed the abscess in (b)(6) 2020, and was prescribed antibiotics.She indicated that the replacement pump was working without issue and the abscess resolved with the antibiotics.Medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed).
Event or Problem Description
On 05/12/020, the customer alleged via chat to medela llc that the freestyle pump she had received in (b)(6) was not emptying her breasts, which had caused her to get an abscess and she had to rent a hospital grade pump for the previous two months.She additionally alleged she had tried replacing the spare parts, but it still did not resolve the issue and she would like to get a different medela pump.
Additional Manufacturer Narrative
The device was returned with the customer's parts and accessories and was evaluated on (b)(6) 2020.The device passed suction and cycle specifications.Refer to attached evaluation.The customer's report of low suction could not be confirmed.

• Brand Name: FREESTYLE W TOTE PT-A 1CT EN
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug,
• MDR Report Key: 10173979
• Report Number: 1419937-2020-00059
• Device Sequence Number: 19673253
• Product Code: HGX
• UDI-Device Identifier: 00020451330921
• UDI-Public: 020451330921
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 101034712
• Device Catalogue Number: 101034712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Congenital Anomaly; Other