MAUDE Adverse Event Report: MEDELA AG SYMPHONY PLUS RENTAL; PUMP, BREAST, POWERED

Model Number	01526
Health Effect - Clinical Codes	Inflammation (1932); Breast Feeding Problem (4829)
Date of Event	12/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer contacted medela for a refund for the month that she did not use the pump.The customer stated that the pump was returned to medela, it has not been received by medela as of the date of this report.The customer was contacted by a complaint handler 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 12/08/2022, the customer alleged to medela llc that the symphony breast pump had low suction even after changes pieces.The customer also alleged that she developed mastitis and is on medication.

• Brand Name: SYMPHONY PLUS RENTAL
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ 6341
• Manufacturer (Section G): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ 6341
• Manufacturer Contact: dave kurudza ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 16013912
• Report Number: 3002807523-2022-00016
• Device Sequence Number: 20473280
• Product Code: HGX
• UDI-Device Identifier: 00020451242156
• UDI-Public: 020451242156
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/20/2022

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: 01526
• Device Catalogue Number: 01526
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/08/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2021
• 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