MAUDE Adverse Event Report: MEDELA AG FREESTYLE HANDS-FREE BREASTPUMP; PUMP, BREAST, POWERED

Model Number	67060
Health Effect - Clinical Codes	Inflammation (1932); Swelling (2091)
Date of Event	04/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A replacement pump in style breast pump was sent to the customer, per her request.In follow up with a complaint handler on 05/09/2018, the customer indicated that she developed mastitis on (b)(6) 2018 and was prescribed an antibiotic.She indicated that the replacement pump was working without issue and the mastitis was resolved.The device was returned with the customer's parts and accessories and was evaluated on 05/18/2018.The device failed suction and cycle specifications.It was identified during the evaluation that the customer's breast shields and media barriers had residue on them.The device was then re-evaluated using a medela lab kit, and it passed suction and cycle specifications.Refer to attached evaluation.It can be reasonably concluded that the customer's report of low suction was attributable to the dirty breast shields and media barrier.Pages 11-13 in the instructions for use provide instructions for cleaning the pump parts and accessories.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 (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 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) 2018, the customer alleged to medela (b)(4) that she was experiencing low suction when double pumping with her freestyle breast pump.During troubleshooting with customer service, the customer indicated that of the two sets of spare parts she has, she is able to get suction with one set.During the troubleshooting, the customer reassembled the parts, tested the pump and indicated that the suction was working.Replacements parts were sent to the customer.On (b)(6) 2018, the customer called back and alleged to medela (b)(4) that she was experiencing low suction again when double pumping with her freestyle breast pump.She alleged that one side does not always have suction when she double pumps, but there is no suction issue when she single pumps.The customer alleged that she was engorged, but was able to relieve the engorgement by herself.

• Brand Name: FREESTYLE HANDS-FREE BREASTPUMP
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ 6341
• MDR Report Key: 7556911
• Report Number: 1419937-2018-00137
• Device Sequence Number: 2436191
• Product Code: HGX
• UDI-Device Identifier: 00020451670607
• UDI-Public: 00020451670607
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K150499
• 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): 05/31/2018

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: 67060
• Device Catalogue Number: 67060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 05/31/2018
• 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