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

Model Number 67060

Device Problems Crack (1135); Structural Problem (2506)

Patient Problem Unspecified Infection (1930)

Event Date 12/08/2017

Event Type  Injury  

Manufacturer Narrative

Replacement spare parts were sent to the customer.In follow up with a complaint handler on 12/27/2017, the customer confirmed that she was diagnosed and treated for a yeast infection.She indicated that the replacement parts were working without issue and that the yeast infection has since resolved.It cannot be definitively concluded that the pump caused or contributed to the customer¿s thrush.Reported issues of thrush were investigated under (b)(4) and the root causes were identified as: lack of education/training to mothers on breast feeding and breast milk pumping; insufficient guidance on breast shield sizing to prevent nipple trauma; insufficient personal hygiene practices prior to breast milk pumping or breast feeding; and no access to or not following the manufactures' instructions for the cleaning and sanitation of the breast milk pumping components.No corrective actions resulted as it was determined that detailed instructions are available and adequate in both printed and on-line formats for cleaning breast milk pumping equipment, personal hygiene, proper breast shield sizing to prevent nipple soreness/trauma, which can lead to skin breaches, allowing for the potential introduction of yeast.

Event Description

On (b)(6) 2017, the customer alleged to medela llc that the back cover on the spare parts for her freestyle breast pump are cracked.She indicated that both she and her baby have thrush, for which she received prescription medications.

• Brand Name: FREESTYLE HANDS-FREE BREASTPUMP
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar, kanton zug, switzerland
• Manufacturer (Section G): MEDELA AG; lattichstrasse 4b; baar, kanton zug 6341 ; SZ 6341
• Manufacturer Contact: robert sokolowski ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 7148995
• MDR Text Key: 95860134
• Report Number: 1419937-2017-00363
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• PMA/PMN Number: K150499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 67060
• Device Catalogue Number: 67060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/20/2017
• Initial Date Manufacturer Received: 12/20/2017
• Initial Date FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other