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

Model Number 57081

Device Problem Insufficient Information (3190)

Patient Problem Inflammation (1932)

Event Date 10/14/2015

Event Type  Injury  

Manufacturer Narrative

A replacement pump was sent to the customer.The original device was received by medela on 10/26/2015.However, as of the date of this report the product evaluation was not complete.Should additional information become available resulting in new, changed, or corrected information, a follow up report will be filed at that time.On (b)(6) 2015 the customer spoke with a medela clinician.The customer reported that she had completed the round of antibiotics and that she had recovered from mastitis with no continued symptoms.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.

Event Description

The customer reported that she had been diagnosed with mastitis while using her pump in style advanced breast pump.Her physician prescribed antibiotics to treat the mastitis.

Manufacturer Narrative

The original device was evaluated by a quality engineer on 2/2/2016.The customer's complaint of low suction was confirmed.The device did not function within specifications.

• Brand Name: PUMP IN STYLE ADVANCED BREASTPUMP STARTER
• 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: 5212240
• MDR Text Key: 30833285
• Report Number: 1419937-2015-00326
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• 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: 10/26/2015
• 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