MAUDE Adverse Event Report: MEDELA INC. PUMP IN STYLE ADVANCED BREASTPUMP STARTER

Model Number 57081

Device Problem Increase in Suction (1604)

Patient Problems Inflammation (1932); Pain (1994); Complaint, Ill-Defined (2331)

Event Date 01/15/2015

Event Type  Injury  

Event Description

The customer reported to customer service on (b)(6) 2014 that she was experiencing high suction with her pump in style advanced breast pump which caused her pain and a torn nipple.During product return follow up with the customer on (b)(6) 2015, the customer reported that she had mastitis.Her ob prescribed dicloxacillin.

Manufacturer Narrative

A new pump was sent to the customer.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 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 re received, resulting in new, changed, or corrected information, a follow up report will be filed at that time.

• Brand Name: PUMP IN STYLE ADVANCED BREASTPUMP STARTER
• Manufacturer (Section D): MEDELA INC.; mchenry IL 60050
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 4448175
• MDR Text Key: 5423321
• Report Number: 1419937-2015-00019
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2015
• 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?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/15/2015
• Date Manufacturer Received: 12/29/2014
• 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