MAUDE Adverse Event Report: MEDELA AG FREESTYLE HANDS FREE; HGX

Model Number 67060

Device Problems Complete Blockage (1094); Decrease in Suction (1146)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2015

Event Type  Injury  

Manufacturer Narrative

A replacement pump was sent to the customer.As of the date of this report the original device has not been received by medela.Should the original device, or additional information become available resulting in new, changed, or corrected data, a follow up report will be filed at that time.It cannot be definitively concluded 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 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) 2015, the customer reported to medela customer service that she was experiencing low suction with her freestyle breast pump.She also reported that she had clogged ducts and mastitis that was treated with clindamycin, that was prescribed by her physician.

Manufacturer Narrative

The device was evaluated on 1/28/2016.The unit performed within specifications.The customer's complaint was not confirmed.

• Brand Name: FREESTYLE HANDS FREE
• Type of Device: HGX
• Manufacturer (Section D): MEDELA AG; laettichstrasse 4b; baar zug, switzerland, CH634 1; SZ CH6341
• Manufacturer (Section G): MEDELA AG; laettichstrasse 4b; baar zug, switzerland, CH634 1; SZ CH6341
• Manufacturer Contact: donald alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8155782270
• MDR Report Key: 5290548
• MDR Text Key: 33316419
• Report Number: 1419937-2015-00350
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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