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

Model Number 67186

Device Problem Decrease in Suction (1146)

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Date 09/22/2016

Event Type  Injury  

Manufacturer Narrative

A replacement pump was sent to the customer.In follow up with a medela clinician on (b)(6) 2016, the customer stated that she had an abscess drained in the emergency room and has been diagnosed with mastitis 3 times for which she was prescribed dicloxacillin and bactrim.The customer also stated that she is abscess free and that her mastitis is resolved at this time.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 on (b)(6) 2016, that her harmony breast pump had low suction.She also reported that she recently had mastitis and a breast abscess.

• 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: 6043246
• MDR Text Key: 57931789
• Report Number: 1419937-2016-00267
• 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: 10/09/2016

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: 10/09/2016
• Initial Date Manufacturer Received: 10/09/2016
• Initial Date FDA Received: 10/20/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other