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

Model Number 8107084 / 57063

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Injury (2348)

Event Date 10/21/2015

Event Type  Injury  

Manufacturer Narrative

The customer was sent size 27mm breast shields.In follow up with the medela clinician, on (b)(6) 2015, the customer reported that she is no longer experiencing pain and that her nipples no longer have cuts and are no longer bleeding.The original breast shields are not being returned for a product evaluation.Should any additional information become available resulting in new, changed, or corrected data, a follow up report will be filed at that time.

Event Description

On (b)(6) 2015 the customer reported, to medela customer service, that the 24mm breast shields for her pump in style advanced breast pump were too small.She also said that she had a breast injury from poor latch, and that she was prescribed a topical antibiotic from her physician to treat the breast injury.

• Brand Name: PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
• Type of Device: HGX
• Manufacturer (Section D): MEDELA INC.; 1101 corporate dr.; mchenry IL 60050
• Manufacturer (Section G): MEDELA INC.; 1101 corporate dr.; mchenry IL 60050
• Manufacturer Contact: donald alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8155782270
• MDR Report Key: 5232412
• MDR Text Key: 31462025
• Report Number: 1419937-2015-00336
• 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: Patient
• Type of Report: Initial
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 8107084 / 57063
• Device Catalogue Number: 8107084 / 57063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2015
• 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
• Patient Outcome(s): Other