MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE ADVANCED ON-THE-GO TOTE; PUMP, BREAST, POWERED

Model Number	101036449
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service conducted troubleshooting with the customer, including verifying correct battery installation and inspecting the power supply for damage.The customer indicated that she tried to power the pump with both power supply and battery pack.The customer was sent a replacement pump and return of the 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 ca11-001, 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 0.008% 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 or mastitis." riordan & wambach, 4th ed.P.294: breastfeeding and human lactation.Mastitis requires prompt medical attention for the mother for pain relief and prescription antibiotics to avoid progression to overwhelming sepsis.
Event or Problem Description
On (b)(6) 2020, the customer alleged to medela llc that her pump in style breast pump would not power on.She additionally alleged that she had mastitis, for which sought medical treatment.
Additional Manufacturer Narrative
The device was returned with the customer's power supply and battery pack and was evaluated on (b)(6)2020.Both the power supply and the battery pack passed a visual inspection.The power supply output voltage, resistance and current were all found to be within specification.The device powered on without issue with both the power supply and the battery pack (using eight lab batteries, as the customer did not return batteries).Refer to attached product evaluation.The customer's report of a power issue could not be confirmed.

• Brand Name: PUMP IN STYLE ADVANCED ON-THE-GO TOTE
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate drive; mchenry, il
• MDR Report Key: 9887853
• Report Number: 1419937-2020-00025
• Device Sequence Number: 11523385
• Product Code: HGX
• UDI-Device Identifier: 00020451364490
• UDI-Public: 020451364490
• Combination Product (Y/N): N
• 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,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: 101036449
• Device Catalogue Number: 101036449
• Device Lot Number: 456624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 05/04/2020
• 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: Other