MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK; PUMP, BREAST, POWERED

Model Number	57062
Health Effect - Clinical Code	Fungal Infection (2419)
Date of Event	01/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed).It cannot be definitively concluded that the pump caused or contributed to the customer's thrush.Reported issues of thrush were investigated under (b)(4) and the root causes were identified as: lack of education/training to mothers on breast feeding and breast milk pumping; insufficient guidance on breast shield sizing to prevent nipple trauma; insufficient personal hygiene practices prior to breast milk pumping or breast feeding; and) no access to or not following the manufactures' instructions for the cleaning and sanitation of the breast milk pumping components.No corrective actions resulted as it was determined that detailed instructions are available and adequate in both printed and on-line formats for cleaning breast milk pumping equipment, personal hygiene, proper breast shield sizing to prevent nipple soreness/trauma, which can lead to skin breaches, allowing for the potential introduction of yeast.
Event or Problem Description
On (b)(6) 2019, the customer alleged to medela llc that she and her baby were being treated for thrush and she expressed concern that the fungi may have been transferred to her pump in style breast pump.The customer also alleged that both she and her baby were undergoing treatment with anti-fungal medication.

• Brand Name: PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate drive; mchenry 60050
• MDR Report Key: 8337027
• Report Number: 1419937-2019-00020
• Device Sequence Number: 16177942
• Product Code: HGX
• UDI-Device Identifier: 00020451570624
• UDI-Public: 00020451570624
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K031614
• 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
• Operator of Device: No Information
• Device Model Number: 57062
• Device Catalogue Number: 57062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 02/13/2019
• 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