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

Model Number 57081

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

Patient Problems Pain (1994); Nipple Sensation Changes (2162)

Event Date 01/05/2018

Event Type  Injury  

Manufacturer Narrative

In follow up with a complaint handler on (b)(6) 2018, the customer indicated that she began to have issues with the pump in style breast pump about the beginning of (b)(6).She indicated that she did not see a doctor, but she was using a prescription nipple cream that she had for cracked nipples, along with an over-the-counter nipple cream.The customer was transferred to customer service for troubleshooting.During troubleshooting, customer service identified that the customer was using 27mm breast shields and had plans to visit a lactation consultant to be fitted for breast shields.They also identified that the pump was making an unusual noise.A replacement pump was sent to the customer.The instructions for use provides instructions for breast shield sizing, including reference to medelabreastshields.Com and referral to a lactation consultant for assistance in choosing the correct size breast shield.Medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed).

Event Description

On (b)(6) 2018, the customer alleged to medela (b)(4) via email that her pump in style breast pump didn't work.She alleged that it was making a "weird sound" when turned up past the first setting and it hurts/damages her nipples.She alleged that she is not getting much milk out and she has replaced the valves, but thinks it is the pump.

• 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
• Manufacturer Contact: jan kloiber ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 7326664
• MDR Text Key: 101970480
• Report Number: 1419937-2018-00076
• 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: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• 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?: No
• Distributor Facility Aware Date: 02/23/2018
• Date Manufacturer Received: 02/22/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other