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

Model Number 01512

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Unspecified Infection (1930); Pain (1994); Chills (2191)

Event Date 07/24/2020

Event Type  Injury  

Manufacturer Narrative

In response to a complaint handler on (b)(6) 2020, the customer confirmed that the mastitis began on (b)(6) 2020, for which she was still taking antibiotics, but she believed that the infection had resolved.Since she had continued issues with breast shield sizing, she was offered the services of a medela clinician, which she accepted.The clinician emailed the customer breast shield sizing guidance and breastfeeding tips and suggestions, with no response from the customer 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 Description

On (b)(6) 2020, the customer alleged to medela llc via email that she had developed mastitis within one day of using the 21mm personal fit flex breast shields with a rented symphony breast pump, after having followed all procedures, including sanitizing them before use.She was previously using the 24mm personal fit breast shields that came with the pump, but was getting nipple blanching and some nipple pain, as too much of her areola was being sucked into the tunnel.She measured her nipple and it measured at 17mm and based on that, using the medela breast shield sizing guide, she determined that she should be using 21mm shields.She ordered the 21mm personal fit flex breast shields and sanitized them the day they were delivered.She woke up the next day with fever and the chills.Her doctor diagnosed her with mastitis and prescribed an antibiotic.She went back to using the 24mm breast shields and, though she was still having discomfort, she felt it was better than the alternative.She stated the only thing she had changed in her pumping routine was the breast shields.

• Brand Name: SYMPHONY RENTAL
• Type of Device: 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: jan kloiber ; 1101 corporate drive; mchenry, il ; 4358316
• MDR Report Key: 10392118
• MDR Text Key: 206374939
• Report Number: 1419937-2020-00081
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 01512
• Device Catalogue Number: 01512
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other