MAUDE Adverse Event Report: MEDELA INC PUMP IN STYLE ADVANCED - ON-THE-GO TOTE; HGX

Model Number 57063

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem Unspecified Infection (1930)

Event Date 01/20/2016

Event Type  Injury  

Manufacturer Narrative

The customer was sent a replacement pump in style.Her mastitis is currently being treated.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.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 on (b)(6) 2016, that her pump in style advanced breastpump would not change phases.The customer reported that she has developed mastitis and was prescribed kelflex 2000 ml per day by her physician.

Manufacturer Narrative

The customer called back on (b)(6) 2016 states her symptoms of mastitis are now gone.The pump in style pump was returned to medela and evaluated on (b)(6) 2016.The evaluation shows that the pump passed all functional tests.

• Brand Name: PUMP IN STYLE ADVANCED - ON-THE-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: robert sokolowski ; 1101 corporate drive; mchenry, IL 60050 ; 8155782220
• MDR Report Key: 5396760
• MDR Text Key: 37029400
• Report Number: 1419937-2016-00016
• 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: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• 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: 02/18/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/20/2016
• Date Manufacturer Received: 02/18/2016
• 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