MAUDE Adverse Event Report: MEDELA AG FREESTYLE HANDS-FREE BREASTPUMP; PUMP, BREAST, POWERED

Model Number 67060

Device Problem Crack (1135)

Patient Problem Unspecified Infection (1930)

Event Date 07/11/2017

Event Type  Injury  

Manufacturer Narrative

Customer service sent the customer replacement valves and membranes.On (b)(6) 2017, during contact with medela clinical personnel, the customer indicated that the replacement valves were working well.She also indicated that she completed her course of antibiotic and was feeling well.Based on the results of (b)(6), 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 that one of the valves was cracked for her pump in style breast pump.She indicated that she developed mastitis for which she was prescribed an antibiotic, though not while using her pump in style breast pump.She developed it while using her sister's freestyle breast pump.

• Brand Name: FREESTYLE HANDS-FREE BREASTPUMP
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ 6341
• Manufacturer (Section G): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• Manufacturer Contact: robert sokolowski ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 6728353
• MDR Text Key: 80557588
• Report Number: 1419937-2017-00202
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• PMA/PMN Number: K150499
• 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: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 67060
• Device Catalogue Number: 67060
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/11/2017
• Initial Date Manufacturer Received: 07/11/2017
• Initial Date FDA Received: 07/20/2017
• 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