MAUDE Adverse Event Report: MEDELA LLC SONATA PUMP W/ FLEX SINGLE 1CT EN FR ES; PUMP, BREAST, POWERED

Model Number 101037319

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

Patient Problems Unspecified Infection (1930); Nipple Ulceration (2441); Blood Loss (2597)

Event Date 03/30/2020

Event Type  Injury  

Manufacturer Narrative

Customer service conducted troubleshooting with the customer, verifying the customers breast shield fit.Following troubleshooting, the customer indicated that the troubleshooting did not resolve her issue of low milk expression.The customer was sent a replacement pump and return of her original pump was requested for testing/evaluation.The customer was contacted by a complaint handler on multiple occasions, including in writing, to get additional information, with no response as of the date of this report.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 (b)(6) 2013 to (b)(6) 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 that her sonata breast pump had not been expressing her milk well, even though the suction felt strong enough.She indicated that if she turned the vacuum level higher, it caused her nipples to crack and bleed, which had to be treated with a prescription compound cream.She further alleged that due to using the pump without proper expression, she developed mastitis, for which she was treated with antibiotics.She had been properly measured for breast shields, and was using the same size as she had with her pump in style breast pump, which works without issue and helped her to clear up the mastitis.

Manufacturer Narrative

The device was returned with the customer's parts and accessories and was evaluated on 05/28/2020.The device passed suction and cycle specifications.Refer to the attached product evaluation.The customer's report of low suction could not be confirmed.

• Brand Name: SONATA PUMP W/ FLEX SINGLE 1CT EN FR ES
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate drive; mchenry, il
• MDR Report Key: 9996297
• MDR Text Key: 191819372
• Report Number: 1419937-2020-00037
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00020451367507
• UDI-Public: 020451367507
• Combination Product (y/n): N
• PMA/PMN Number: K161725
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101037319
• Device Catalogue Number: 101037319
• Device Lot Number: 456293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Date Manufacturer Received: 05/28/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other