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

Model Number	101034712
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service conducted troubleshooting with the customer, including inspecting, cleaning and reassembling the kit and tubing set.The troubleshooting did not resolve the issue.The customer was sent a replacement pump and return of her original pump was requested for testing/evaluation.In follow up with a complaint handler on 04/27/21, the customer indicated her replacement pump was working great and she had returned her original breast pump to medela.Based on the results of our internal investigation (reference number (b)(4)),it cannot be definitively concluded that the pump caused or contributed to the customer's mastitis.The estimated incidence of mastitis in lactating women, whether using a breast pump or not, according to published clinical literature can be as high as 33%.In fact, clinical guidelines suggest the use of a breast pump to facilitate withdrawal of breast milk during bouts of mastitis.The complaint rate of mastitis across all reported failures, across all medela breast pumps, is (b)(4) for the period of january 2013 to august 2017.Mastitis is usually a benign, self-limiting infection with few consequences for the suckling infant.The risk of mastitis is higher among women who have breastfed previously, especially those with a history of mastitis.Riordan & wambach, 4th ed.P.294: breastfeeding and human lactation.However in this case, the mother's mastitis required prompt medical attention for pain relief and prescription antibiotics to avoid progression to overwhelming sepsis.
Event or Problem Description
On (b)(6) 2021 the customer alleged to medela llc that her freestyle breast pump had low suction and she had mastitis, for which she was prescribed an antibiotic.

• Brand Name: FREESTYLE W TOTE PT-A 1CT EN
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug, 6341 ; SZ 6341
• MDR Report Key: 11793933
• Report Number: 1419937-2021-00037
• Device Sequence Number: 14318743
• Product Code: HGX
• UDI-Device Identifier: 00020451330921
• UDI-Public: 020451330921
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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: 101034712
• Device Catalogue Number: 101034712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 05/07/2021
• 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: Other