MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE ADVANCED - ON-THE-GO TOTE; PUMP, BREAST, POWERED

Model Number 57063/9207010

Device Problems Break (1069); Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/12/2017

Event Type  malfunction  

Manufacturer Narrative

A replacement adapter 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.The cause of the breach in the rev n transformer has not been determined at this time.  it is currently being investigated under ir (b)(4).

Event Description

The customer reported to customer service on (b)(6) 2017, that the adapter to her pump in style breast pump housing cracked and she can see the wires.

• Brand Name: PUMP IN STYLE ADVANCED - ON-THE-GO TOTE
• 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: 6523418
• MDR Text Key: 74147431
• Report Number: 1419937-2017-00125
• 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: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 57063/9207010
• Device Catalogue Number: 57063/9207010
• Device Lot Number: REV N 1313
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/12/2017
• Initial Date Manufacturer Received: 04/12/2017
• Initial Date FDA Received: 04/26/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1