MAUDE Adverse Event Report: MEDELA AG SWING CANADA/AG; PUMP, BREAST, POWERED

Model Number	27276
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/2020
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.In follow up with a complaint handler on 09/30/2020, the customer indicated that she developed mastitis in (b)(6) 2020, and was prescribed an antibiotic.She indicated that she received the replacement pump and her mastitis was resolved.The device was returned without the customer's parts or accessories and was evaluated on 10/07/2020.It was found in the product evaluation that the pump motor had dried milk inside it.The motor turns on but suction was low due to milk overflow.The customer's report of low suction was confirmed.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 09/21/2020, the customer alleged to medela canada that she was experiencing low suction with her swing breast pump.It will power on but there is no vacuum action from the motor.She indicated she had mastitis and needed a functional breast pump as soon as possible.

• Brand Name: SWING CANADA/AG
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug, 6341 ; SZ 6341
• MDR Report Key: 10711470
• Report Number: 1419937-2020-00119
• Device Sequence Number: 19648050
• Product Code: HGX
• UDI-Device Identifier: 00020451670508
• UDI-Public: 020451670508
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K053052
• 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: 27276
• Device Catalogue Number: 27276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/21/2020
• 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