MAUDE Adverse Event Report: MEDELA, INC. PUMP IN STYLE ADVANCED BREAST PUMP; HGX

Model Number 57081

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Unspecified Infection (1930); Occlusion (1984)

Event Date 05/26/2015

Event Type  Injury  

Event Description

The customer reported to customer service that she developed clogged ducts while using the pump in style advanced breast pump.A medela clinician followed up with the customer on (b)(6) 2015.The customer states she developed an abscess, which was drained and she was prescribed dicloxacillin by her physician.The customer states that the replaced pump is working properly.The customer had also been putting the baby to the breast trying to latch in addition to using the pump when the mastitis/abscess occurred.

Manufacturer Narrative

A replacement pump was sent to the customer.It cannot be definitely concluded that the pump caused or contributed to the customer's mastitis/abcess.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 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.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.

Manufacturer Narrative

The pump was returned to medela and evaluated on 10/08/2015, the evaluation showed the unit passed all functional tests.See attached product evaluation.

• Brand Name: PUMP IN STYLE ADVANCED BREAST PUMP
• Type of Device: HGX
• Manufacturer (Section D): MEDELA, INC.; mchenry IL
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 4843534
• MDR Text Key: 16176982
• Report Number: 1419937-2015-00180
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 57081
• Device Catalogue Number: 57081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2015
• Distributor Facility Aware Date: 05/26/2015
• Date Manufacturer Received: 10/08/2015
• 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