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

Model Number 67186

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 06/26/2016

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.

Event Description

On 7/7/2016 the customer contacted a medela customer service representative.She reported that the diaphragm on the handle for her harmony breast pump, was slipping out of place.She also reported that she was diagnosed with mastitis on (b)(6) 2016 and prescribed dicloxacillin to treat the mastitis.She has completed the antibiotics.

• Brand Name: HARMONY MANUAL BREASTPUMP
• Type of Device: PUMP, BREAST, NON-POWERED
• Manufacturer (Section D): MEDELA, INC; 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: 5850206
• MDR Text Key: 51261512
• Report Number: 1419937-2016-00201
• Device Sequence Number: 1
• Product Code: HGY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/07/2016

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: 67186
• Device Catalogue Number: 67186
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/07/2016
• Initial Date Manufacturer Received: 07/07/2016
• Initial Date FDA Received: 08/05/2016
• 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