MAUDE Adverse Event Report: MEDELA LLC BREASTPUMP PNSA STARTER; PUMP, BREAST, POWERED

Model Number 57081

Device Problems Device Inoperable (1663); Noise, Audible (3273)

Patient Problem Unspecified Infection (1930)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

A replacement pump was sent to the customer.In follow up with a medela clinician on (b)(6) 2017, the customer stated that her ob/gyn diagnosed her with mastitis and prescribed dicloxicillin for 10 days.In a continued follow up with the medela clinician on (b)(6) 2017, the customer stated that she finished her antibiotic but she was experiencing deep breast pain and she went back to see her doctor and she was diagnosed with a yeast infection and was prescribed medication.She also stated that she has had repeated mastitis and yeast infections 3 months ago.A medela clinician followed up with the customer again on (b)(6) 2017, and the customer stated that the doctor prescribed diflucan for her yeast infection.The customer stated that the mastitis is resolved.The pump passed all functional test.The qe noted that there was dirt on the diaphragm and faceplate.See attached evaluation.It cannot be definitively concluded that the pump caused or contributed to the customer¿s yeast infection.Reported issues of thrush/yeast are under investigation in (b)(4).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 to customer service that her pump in style advance was making a loud knocking noise and was not working.The customer stated she developed mastitis.

• Brand Name: BREASTPUMP PNSA STARTER
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• Manufacturer Contact: robert sokolowski ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 6391701
• MDR Text Key: 69495233
• Report Number: 1419937-2017-00068
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• PMA/PMN Number: K031614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• 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
• Device Lot Number: 429164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Distributor Facility Aware Date: 02/22/2017
• Date Manufacturer Received: 02/22/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other