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

Model Number 57XXX

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Inflammation (1932)

Event Date 11/25/2015

Event Type  Injury  

Manufacturer Narrative

Should additional information be received, resulting in new, changed, or corrected information, a follow up report will be filed at that time.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.It cannot be definitively concluded that the pump caused or contributed to the customer's mastitis.Reported issues of mastitis are under investigation in (b)(4).Mastitis is usually a benign, self-limiting infection with few consequences for the suckling infant.The risk of mastitis is higher among women who have breastfed previously, especially those with a history or mastitis." riordan & wambach, 4th ed.P.294: breastfeeding and human lactation mastitis requires prompt medical attention for the mother for pain relief and prescription antibiotics to avoid progression to overwhelming sepsis.

Event Description

The customer reported to customer service on (b)(6) 2015, that she had mastitis in the past.On (b)(6) 2015, she confirmed with a medela clinician that her mastitis was diagnosed by her physician and that she was prescribed keflex for treatment.Her mastitis has been resolved.

Manufacturer Narrative

At the time of the initial medwatch filing, the product was not received and evaluated.The product was received on 12/29/2015 and evaluated by quality engineering on 2/5/2016.A product evaluation revealed that the breast pump did not pass functional tests and the technician observed a broken/damaged diaphragm.A broken/damaged dc plug black ring was also noted on the power adaptor.The customer reported issue of low suction was confirmed.

• Brand Name: PUMP IN STYLE ADVANCED BREAST PUMP
• 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: 5354755
• MDR Text Key: 35530729
• Report Number: 1419937-2016-00006
• 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,user facility
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 57XXX
• Device Catalogue Number: 57XXX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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