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

Model Number	01512
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service sent the customer a replacement device and return of her original device was requested for testing/evaluation.In follow up with a complaint handler on 06/09/2020, the customer indicated she had several episodes of mastitis, but it was controlled after taking antibiotics.She additionally indicated that she had determined that the low suction had been caused by a kit assembly issue and a damaged membrane, which she had discarded, and she was now using the pump without issue.The customer was subsequently contacted by a complaint handler, including in writing, to get information on whether mastitis the mastitis had since resolved, with no response as of the date of this report.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) 2020, the customer alleged to medela llc that her symphony breast pump had low suction and had not been emptying her breasts.She additionally alleged that she was prescribed antibiotics for mastitis, but one week later her mastitis had worsened and she was prescribed additional antibiotics.She indicated that she was in need of a replacement pump and would be visiting her doctor that day for a follow up appointment.

• Brand Name: SYMPHONY RENTAL
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug, 6341 ; SZ 6341
• MDR Report Key: 10199726
• Report Number: 1419937-2020-00062
• Device Sequence Number: 2612903
• Product Code: HGX
• UDI-Device Identifier: 07612367007566
• UDI-Public: 7612367007566
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151632
• 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: Lay User/Patient
• Device Model Number: 01512
• Device Catalogue Number: 01512
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 06/26/2020
• 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