MAUDE Adverse Event Report: MEDELA AG SYMPHONY RENTAL; PUMP, BREAST, POWERED

Model Number 01512

Device Problem Contamination (1120)

Patient Problem Staphylococcus Aureus (2058)

Event Date 05/11/2017

Event Type  Injury  

Manufacturer Narrative

The customer was sent a replacement breast pump kit.In follow-up with a medela clinician on (b)(6) 2017, the customer indicated that she has taken clindamycin 300mg for 10 days in (b)(6), but because she is still having drainage from both nipples, she was recently prescribed dicloxicillin, but she hasn't started to take it.Based on the results of (b)(4), it cannot be definitively concluded that the pump caused or contributed to the customer¿s mastitis.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) 2017, the customer alleged to customer service that she developed a staph infection in her nipples while using a medela symphony rental breast pump and was prescribed an antibiotic.

• Brand Name: SYMPHONY RENTAL
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA AG; baar zug 6341 ; SZ 6341
• Manufacturer (Section G): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ 6341
• Manufacturer Contact: robert sokolowski ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 6630157
• MDR Text Key: 77275954
• Report Number: 1419937-2017-00167
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 01512
• Device Catalogue Number: 01512
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/11/2017
• Date Manufacturer Received: 05/11/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other