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

Model Number 57081

Device Problem Obstruction of Flow (2423)

Patient Problem Fungal Infection (2419)

Event Date 09/08/2015

Event Type  Injury  

Manufacturer Narrative

The customer was sent a replacement pump.It cannot be definitively concluded that the pump caused or contributed to the customer's thrush.Reported issues of thrush are under investigation in (b)(4).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.Should additional information or the original product be received, resulting in new, changed, or corrected information, a follow up report will be filed at that time.

Event Description

The customer reported to customer service that she had milk backup into the motor of her pump in style advanced starter.The customer also stated that she has thrush and is taking nystatin and oral difflucan.

Manufacturer Narrative

The pump was returned to medela and evaluated on 10/07/2015, the evaluation showed that the pump passed all functional tests.

• Brand Name: PUMP IN STYLE ADVANCED 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: 5099137
• MDR Text Key: 26595589
• Report Number: 1419937-2015-00281
• 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
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 09/27/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2015
• 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