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

Model Number	57063
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An email response was sent to the customer, requesting that she contact customer service via phone so that her issue could be appropriately be addressed.In follow up with a complaint handler on (b)(6) 2019, the customer indicated that she had developed mastitis, for which she was prescribed antibiotics, and had experienced an extreme decrease in milk supply.The customer was contacted subsequently by a complaint handler on multiple occasions, including in writing, to confirm if the mastitis had been resolved and to request that she contact customer service, which the customer did on (b)(6) 2019, at which point she was sent a replacement battery pack return of her original battery pack was requested for testing/evaluation.Based on the results of (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 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) 2019, the customer emailed medela llc alleging that the battery pack for her pump in style breast pump was not powering the pump, despite the fact that she used brand new batteries.She further alleged that it caused her to become engorged at work.
Additional Manufacturer Narrative
The device was returned with the customer's parts and accessories, except for the membranes, and was evaluated on (b)(6)2019.The device did not pass the power test when using the customer's battery pack with 8 aa batteries, but did pass the power test when using the customer's power supply.It was noted in the evaluation that the customer's battery pack had broken/damaged contacts.It was also noted during the evaluation that the customer's breast shield connector's and tubing had residue on them.Refer to attached evaluation and pictures.The customer's report of the breast pump not powering on when using the battery pack was confirmed.

• Brand Name: PUMP IN STYLE ON THE GO TOTE
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• MDR Report Key: 8354831
• Report Number: 1419937-2019-00025
• Device Sequence Number: 11297311
• Product Code: HGX
• UDI-Device Identifier: 00020451570631
• UDI-Public: 00020451570631
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: 57063
• Device Catalogue Number: 57063
• Device Lot Number: 447135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 03/21/2019
• 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