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

Model Number 9207012/57062

Device Problems Break (1069); Crack (1135)

Patient Problem No Information (3190)

Event Date 01/20/2015

Event Type  malfunction  

Event Description

The customer called into customer service to report that her pump in style transformer housing is cracked and she has to tape the adaptor together, indicating a breach, which is a safety risk.

Manufacturer Narrative

A replacement transformer was sent to the customer.The prod involved in this complaint has not been returned for eval/investigation at this time.Therefore no conclusion can be made as to the cause of the event.Should add'l info or the original prod be rec'd, resulting in new, changed, or corrected info, 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 ir 13-0154.

• Brand Name: PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK
• Manufacturer (Section D): MEDELA, INC.; mchenry IL 60050
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 4460482
• MDR Text Key: 16991031
• Report Number: 1419937-2015-00023
• 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: 01/20/2015

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: 9207012/57062
• Device Catalogue Number: 9207012/57062
• Device Lot Number: REV N -3113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/20/2015
• Initial Date Manufacturer Received: 01/20/2015
• Initial Date FDA Received: 01/26/2015
• 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