MAUDE Adverse Event Report: MEDELA AG SWING BREASTPUMP; PUMP, BREAST, POWERED

Model Number 67050

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Unspecified Infection (1930); Swelling (2091); Injury (2348)

Event Date 02/26/2018

Event Type  Injury  

Manufacturer Narrative

The customer was sent a replacement pump and return of her original pump was requested for testing/evaluation.Attempts to contact the customer to get additional information are on-going.Based on the results of (b)(4) , it cannot be definitively concluded that the pump caused or contributed to the customer¿s mastitis.The estimated incidence of mastitis in lactating women, whether using a breast pump or not, according to published clinical literature can be as high as 33%.In fact, clinical guidelines suggest the use of a breast pump to facilitate withdrawal of breast milk during bouts of mastitis.The complaint rate of mastitis across all reported failures, across all medela breast pumps, is (b)(4)% for the period of january 2013 to august 2017.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

On (b)(6) 2018 the customer alleged to medela (b)(4) that her swing breast pump injured her and her breast became swollen and red because of use.The customer further alleged that she developed mastitis and visited her physician last month for care and antibiotics.

Manufacturer Narrative

The customer was contacted by a complaint handler on multiple occasions, including in writing, to get additional information, with no response as of the date of this report.The device was returned with the customer's parts and accessories and was evaluated on 04/06/2018.The device passed suction and cycle specifications.Refer to attached evaluation.[(b)(4)].

• Brand Name: SWING BREASTPUMP
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ 6341
• Manufacturer (Section G): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ 6341
• Manufacturer Contact: jan kloiber ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 7322982
• MDR Text Key: 101836807
• Report Number: 1419937-2018-00073
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 67050
• Device Catalogue Number: 67050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/26/2018
• Date Manufacturer Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other