MAUDE Adverse Event Report: MEDELA AG HARMONY MANUAL BREASTPUMP; PUMP, BREAST, NON-POWERED

Model Number 8107084/67186

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

Patient Problem Unspecified Infection (1930)

Event Date 09/11/2016

Event Type  Injury  

Manufacturer Narrative

In follow up with a medela clinician on (b)(6) 2016, the customer stated she had mastitis and it started on (b)(6) 2016, and had taken 2 courses of antibiotics prescribed by a breast specialist.The customer stated her mastitis has been resolved.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.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 that her breastshields to her harmony breastpump was too large and that she had mastitis.

• Brand Name: HARMONY MANUAL BREASTPUMP
• Type of Device: PUMP, BREAST, NON-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: robert sokolowski ; 1101 corporate drive; mchenry, IL 60050 ; 8155782220
• MDR Report Key: 6033788
• MDR Text Key: 57625245
• Report Number: 1419937-2016-00264
• Device Sequence Number: 1
• Product Code: HGY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K823840
• 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: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 8107084/67186
• Device Catalogue Number: 8107084/67186
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/15/2016
• Date Manufacturer Received: 10/07/2016
• 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