MAUDE Adverse Event Report: MEDELA, INC. PUMP IN STYLE MEDICAL ASSISTANCE BREAST PUMP

Model Number 57038

Device Problem Increase in Suction (1604)

Patient Problems Erythema (1840); Unspecified Infection (1930); Pain (1994)

Event Date 12/20/2013

Event Type  Injury  

Event Description

The customer stated her breast pump suction was too high, which made her nipples red and soar, and caused an infection.At the time of the call, there was no indication that the infection progressed into mastitis.During the clinical assessment on (b)(6) 2014, the customer stated her obgyn diagnosed her with mastitis and was treated with antibiotics.

Manufacturer Narrative

A replacement breast pump was sent to the customer and requested the defective breast pump be returned for eval.The defective breast pump was received at medela on (b)(4) 2014.Though the product has been received, it has not yet been tested/analyzed by quality engineering.Therefore, no conclusions can be made as to the cause of the event.A medela clinician spoke to the customer on (b)(4) 2014, at which time the customer states her baby is still in nicu.Her obgyn diagnosed her with a mastitis infection and was prescribed antibiotics.She states her mastitis infection is resolved.She feels her hospital grade breast pump is more effective than her pump in style breast pump she uses at home.The customer states her milk supply is still low from her mastitis infection.The clinician informed her that the use of a symphony pump is most effective for increasing supply.Without report of continued symptoms, this issue is resolved with no permanent adverse effects to the customer.No further f/u is necessary."mastitis is usually a benign, self-limiting infection with few consequences for suckling infant.The risk of mastitis is higher among women who have breastfed previously, especially those with a history or mastitis." ["breastfeeding and human lactation" (riordan and wambach, 4th edition,page 294)].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).

• Brand Name: PUMP IN STYLE MEDICAL ASSISTANCE BREAST PUMP
• Manufacturer (Section D): MEDELA, INC.; mchenry IL 60050
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 3624772
• MDR Text Key: 4206303
• Report Number: 1419937-2014-00130
• 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: 12/20/2013,01/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 57038
• Device Catalogue Number: 57038
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/20/2014
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/20/2013
• Date Manufacturer Received: 12/20/2013
• 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