MAUDE Adverse Event Report: MEDELA, INC. PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG

Model Number 57063

Device Problem Increase in Suction (1604)

Patient Problems Pain (1994); Fungal Infection (2419)

Event Date 02/12/2015

Event Type  Injury  

Event Description

The customer reported that her suction was high on her pump in style breast pump and she was having pain while pumping, mom stated she also had a yeast infection.The customer met with an lc and a doctor and given a topical treatment nystatin and oral diflucan.

Manufacturer Narrative

A medela clinician spoke to the customer on (b)(6) 2015, at which time the customer indicated that she rec'd a replacement pns sent by cs and it was working for her.She was taken a topical treatment of nystatin and oral diflucan.Customer indicated she is doing much better, further clinical f/u in not indicated.The breast pump was returned by the customer for testing/analysis.See eval summary.Which indicates that the pump was operating within spec.Based on the fact that the pump tested to spec, it cannot be definitively concluded that the pump caused the thrush.

• Brand Name: PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG
• Manufacturer (Section D): MEDELA, INC.; mchenry IL 60050
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 4612074
• MDR Text Key: 5660853
• Report Number: 1419937-2015-00084
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2015
• 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: 5763
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/27/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2015
• 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