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

Model Number 57063

Device Problem Increase in Suction (1604)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 04/08/2015

Event Type  Injury  

Event Description

The customer reported that the suction on her pump in style breast pump was high and that she had cracked nipples.She also stated that she had received antibiotics and prescription ointments from her physician to help treat and heal the cracks and an infection.

Manufacturer Narrative

A replacement pump was sent to the customer.In f/u with a medela clinician on (b)(4) 2015, the customer stated that the replacement pump is better than the original.She also stated that she has finished the initial round of antibiotics, is not using a prescription ointment, and that she is still under the care of her physician and lactation consultant.As of the date of this report, the original product has not been received.Should the original product or additional info be received resulting in new, changed, or corrected info, a f/u report will be filed at that time.Issues for suction on the pump in style device are being addressed under ir11-0140.

• Brand Name: PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
• Type of Device: HGX
• Manufacturer (Section D): MEDELA, INC.; mchenry IL
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 4761739
• MDR Text Key: 5787491
• Report Number: 1419937-2015-00129
• 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: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 57063
• Device Catalogue Number: 57063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/08/2015
• Date Manufacturer Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other