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

Model Number 67060

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 09/20/2017

Event Type  Injury  

Manufacturer Narrative

At the customer's request, she was sent a pump in style as a replacement for the freestyle breast pump.Multiple attempts to contact the customer to get additional information went unanswered.Though the complaint information does not reasonably suggest that the device caused or contributed to the injury or the device malfunctioned, medela is filing this report, which is considered a serious injury as it required medical attention.

Event Description

On (b)(6) 2017, the customer alleged to medela (b)(4) that her lactation consultant told her that the pressure on her freestyle breast pump was low and her nipples were cracked and very painful.The customer called back the same day and further explained that when she pumps at level 7 it was painful, but if she goes below that level, the pump would not express milk.She was using 27mm breast shields after getting fitted by the lactation consultant.The customer stated that she was on prescription medication and nipple cream to help heal her cracked nipples and that she has switched to a hospital grade breast pump.

Manufacturer Narrative

The customer's pump was evaluated with the parts and accessories which were returned by the customer and it failed vacuum testing.Additional testing indicated that the root cause of the low suction issue can be attributed to a molding deficiency on the connectors sealing surface.Currently there is an open investigation (capa-(b)(4)), which identified molding enhancements to correct this deficiency which were put in place in july of 2017.

Manufacturer Narrative

Corrected the date in date received by mfr., which was erroneously excluded in follow up #1.

• Brand Name: FREESTYLE HANDS-FREE BREASTPUMP
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ 6341
• Manufacturer (Section G): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ 6341
• Manufacturer Contact: robert sokolowski ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 6954247
• MDR Text Key: 89473140
• Report Number: 1419937-2017-00289
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/20/2017
• Date Manufacturer Received: 11/08/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other