MAUDE Adverse Event Report: MEDELA INC. HARMONY RETAIL; HGY

Model Number 67186

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem Unspecified Infection (1930)

Event Date 10/15/2015

Event Type  Injury  

Manufacturer Narrative

A replacement pump was sent to the customer.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 can not be definitively concluded that the pump caused or contributed to the customer's thrush.Reported issues of thrush are under investigation in (b)(4).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 has mold on her harmony pump, and states she cleans it after every use.The customer also reported that she and the baby have thrush and have been prescribed an antibiotic.

• Brand Name: HARMONY RETAIL
• Type of Device: HGY
• 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: 5167210
• MDR Text Key: 28907804
• Report Number: 1419937-2015-00309
• Device Sequence Number: 1
• Product Code: HGY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/15/2015

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: 67186
• Device Catalogue Number: 67186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/15/2015
• Initial Date FDA Received: 10/21/2015
• 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