MAUDE Adverse Event Report: MEDELA, INC. PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

Model Number 8107084-57063

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 03/10/2014

Event Type  Injury  

Event Description

The customer reported to customer service that the 24mm breastshields were causing her pain.F/u with the customer confirmed she had mastitis.

Manufacturer Narrative

Customer service sent replacement breastshields to the customer.In f/u with the customer, she stated that she had mastitis.She also indicated that her baby was having trouble latching onto her breast.She was diagnosed and treated for mastitis.She confirmed that the new breast shields were much better.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 to avoid progression to overwhelming sepsis.

• Brand Name: PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
• Manufacturer (Section D): MEDELA, INC.; mchenry IL
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 3760978
• MDR Text Key: 4465028
• Report Number: 1419937-2014-00345
• Device Sequence Number: 1
• Product Code: HFS
• 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: 03/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 8107084-57063
• Device Catalogue Number: 8107084/57063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/10/2014
• Date Manufacturer Received: 03/10/2014
• Was Device Evaluated by Manufacturer?: No
• 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