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

Model Number 57063

Device Problem Increase in Suction (1604)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Complaint, Ill-Defined (2331)

Event Date 07/17/2015

Event Type  Injury  

Event Description

The customer reported that she was experiencing high suction with her pump in style breast pump.She stated that her nipples were cracked and bleeding and that she had experienced clogged ducts.The customer also reported that she had mastitis and was prescribed keflex, an antibiotic, by her physician.

Manufacturer Narrative

A replacement pump was sent to the customer.Attempts to contact the customer for further information are ongoing.Should additional information become available resulting in new, changed, 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 & 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.

Manufacturer Narrative

The original device was evaluated by a quality engineer on 2/2/2016.The customer's complaint cannot be confirmed.The unit functioned within specifications.

• Brand Name: PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
• Type of Device: HGX
• Manufacturer (Section D): MEDELA INC.; 1101 corporate dr.; mchenry IL 60050
• Manufacturer (Section G): MEDELA INC.; 1101 corporate dr.; mchenry IL 60050
• Manufacturer Contact: donald alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8155782270
• MDR Report Key: 4936639
• MDR Text Key: 6050924
• Report Number: 1419937-2015-00235
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 57063
• Device Catalogue Number: 57063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2016
• 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