MAUDE Adverse Event Report: MEDELA LLC SOLO BREAST PUMP; PUMP, BREAST, POWERED

Model Number	101041624
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service conducted troubleshooting including; verifying user was using correct kit components; verifying user was washing parts according to instructions for use; verifying the user was using dry parts when pumping; disassembled, inspected, cleaned, and reassembled kit and tubing set; verifying using correct breast shield size; and powering the pump on and off.The customer was sent a replacement pump and 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.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) 2022, the customer alleged to medela canada that her solo breast pump had no suction.She additionally reported she has mastitis and is on antibiotics.She will be going to her doctor to get an ultrasound.

• Brand Name: SOLO BREAST PUMP
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry, il
• Manufacturer (Section G): MEDELA LLC; 1101 corporate dr; mchenry, il
• Manufacturer Contact: dave kurudza ; 1101 corporate dr; mchenry, il ; 4358316
• MDR Report Key: 15156991
• Report Number: 1419937-2022-01000
• Device Sequence Number: 14782585
• Product Code: HGX
• UDI-Device Identifier: 00020451436142
• UDI-Public: 020451436142
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K210759
• 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: 101041624
• Device Catalogue Number: 101041624
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female