MAUDE Adverse Event Report: MEDELA INC. PUMP IN SYLE ADVANCED BREAST PUMP BACKPACK

Model Number 57062

Device Problem Suction Problem (2170)

Patient Problems Inflammation (1932); Occlusion (1984)

Event Date 10/13/2014

Event Type  Injury  

Event Description

The customer reported to customer service on (b)(6) 2014 that she is noticing low milk expression while using her pns.She has mastitis and clogged ducts, for which she saw her physician, who prescribed antibiotics.

Manufacturer Narrative

Replacement parts have been sent to the customer.The customer reporting that she was seen by an urgent care doctor, her regular doctor and a lactation consultant.She was prescribed clindamycin (antibiotic) 300mg 3xs a day for mastitis and clogged ducts.Should additional information or the original product be received, resulting in new, change,d or corrected information, 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 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.(b)(4).

• Brand Name: PUMP IN SYLE ADVANCED BREAST PUMP BACKPACK
• Manufacturer (Section D): MEDELA INC.; mchenry IL 60050
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 4193505
• MDR Text Key: 17991157
• Report Number: 1419937-2014-00790
• 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: 10/13/2014,10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 57062
• Device Catalogue Number: 57062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/13/2014
• Date Manufacturer Received: 10/13/2014
• 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
• Patient Outcome(s): Other