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

Model Number 67186

Device Problem Suction Problem (2170)

Patient Problem Unspecified Infection (1930)

Event Date 05/23/2016

Event Type  Injury  

Manufacturer Narrative

A replacement pump was sent to the customer.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.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.Should additional information be received, resulting in new, changed, or corrected information, a follow up report will be filed at that time.

Event Description

The customer reported to customer service on 05/23/2016, that her harmony breast pump had low suction and she developed mastitis and was prescribed an antibiotic.

• 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; barr zug 6341 ; SZ 6341
• Manufacturer Contact: robert sokolowki ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 5736666
• MDR Text Key: 47772436
• Report Number: 1419937-2016-00152
• 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: 05/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 67186
• Device Catalogue Number: 67186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2016
• Distributor Facility Aware Date: 05/23/2016
• Date Manufacturer Received: 05/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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