MAUDE Adverse Event Report: MEDELA AG FREESTYLE HANDS FREE

Model Number 67060

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Occlusion (1984)

Event Type  Injury  

Event Description

The customer reported to customer service on (b)(6) 2015 that she was experiencing clogged ducts and mastitis while using her freestyle hands free breast pump.Her baby also had thrush.She was on antibiotics and the baby is on nystatin.Both issues have been resolved.

Manufacturer Narrative

The customer was sent a replacement pump: the product involved in the complaint was not returned for evaluation/investigation at this time.Therefore, no conclusions can be made as to the cause of the event.Should additional information or the original product be received, resulting in new, changed, or corrected information, a follow up report will be filed at that time.It cannot be definitively conducted that the pump caused or contributed to the customer's mastitis.Reported issues of mastitis are under investigation in (b)(4).Mastitis is usually a benign, self-limiting infection with few consequences fo the suckling infant.The risk of mastitis is higher among women who have breastfed previously, especially those with a history of mastitis." riordan and 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.

• Brand Name: FREESTYLE HANDS FREE
• Manufacturer (Section D): MEDELA AG; baar ; SZ
• Manufacturer (Section G): MEDELA AG; lattichstrasse 4b; baar 6341 ; SZ 6341
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 4776949
• MDR Text Key: 5797805
• Report Number: 1419937-2015-00145
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 05/11/2015
• Date Manufacturer Received: 05/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other