MAUDE Adverse Event Report: MEDELA AG LACTINA SELECT BREAST PUMP; HGX

Model Number 016SC01

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

Patient Problem Inflammation (1932)

Event Date 09/19/2015

Event Type  Injury  

Manufacturer Narrative

The customer was sent replacement parts for her pump.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.Should additional information or the original product be received, resulting in new, changed, or corrected information, a follow up report will be filed at that time.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 was having low milk expression while using the lactina breast pump.The customer was confused about breast shield sizing and she also stated that while breastfeeding her daughter, her daughter bit her and she developed mastitis and was treated with antibiotics.Her mastitis is now resolved.

Manufacturer Narrative

On (b)(4) 2015 a medela clinician spoke with the customer who stated she took keflex 500 mg twice a day for 10 days & her mastitis is resolved.

• Brand Name: LACTINA SELECT BREAST PUMP
• Type of Device: HGX
• Manufacturer (Section D): MEDELA AG; laettichstrasse 4b; baar zug, switzerland, CH634 1; SZ CH6341
• Manufacturer (Section G): MEDELA AG; laettichstrasse 4b; baar zug, switzerland, CH634 1; SZ CH6341
• Manufacturer Contact: donald alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8155782270
• MDR Report Key: 5147872
• MDR Text Key: 28183088
• Report Number: 1419937-2015-00299
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K875300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Followup
• Report Date: 09/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 016SC01
• Device Catalogue Number: 016SC01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2015
• 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