MAUDE Adverse Event Report: MEDELA, INC. PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

Model Number 9207010/57063

Device Problems Break (1069); Crack (1135); Protective Measures Problem (3015); Scratched Material (3020)

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

Event Date 01/06/2015

Event Type  malfunction  

Event Description

The customer called in to customer service to report that her pump in style transformer housing is cracked and damaged and there are exposed wires, indicating a breach which is a safety risk.

Manufacturer Narrative

A replacement power supply was sent to the customer.The product involved in the complaint was not returned for evaluation/investigation at the time of this report.Therefore, no conclusion can be made as to the cause of the event.Should additional information or the original product be received, resulting in new, changed, or correct information a follow up report will be filed at that time.The cause of the breach in the rev n transformer has not been determined at this time.It is currently being investigated under (b)(4).

• Brand Name: PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
• Manufacturer (Section D): MEDELA, INC.; mchenry IL 60050
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 4432408
• MDR Text Key: 19984520
• Report Number: 1419937-2015-00010
• 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: 01/14/2015

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: 9207010/57063
• Device Catalogue Number: 9207010/57063
• Device Lot Number: REV N - UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/06/2015
• Initial Date Manufacturer Received: 01/06/2015
• Initial Date FDA Received: 01/16/2015
• 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