MAUDE Adverse Event Report: MEDELA, INC. BREASTPUMP PNSA STARTER; PUMP, BREAST, POWERED

Model Number 57081

Device Problem Decrease in Suction (1146)

Patient Problem Inflammation (1932)

Event Date 02/05/2016

Event Type  Injury  

Manufacturer Narrative

The customer was sent a replacement breastpump.Should additional information or the original product be received, resulting in new, changed, or corrected information, a follow up report will be filed at that time.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.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.

Event Description

On (b)(6) 2016 the customer contacted customer service to report she was having low suction with her pump in style advanced starter breastpump.She also reported that she previously had mastitis while using our pump and was prescribed dicloxacillin by her physician.

Manufacturer Narrative

The customer reported to a medela clinician on (b)(6) 2016 that she previously had mastitis and was prescribed dicloxacillin.She no longer is experiencing symptoms of mastitis.

Manufacturer Narrative

At the time of the initial medwatch filing, the product was not received and evaluated.The product was received at medela on 03/07/2016 and evaluated by quality engineering on 04/13/2016.A product evaluation revealed that the device did not pass the vacuum test when tested with the customer's returned kit components; it was noted in the evaluation that the customers membrane and valve had damage.The breast pump passed functional tests and operated within specifications when tested with the lab kit components.

• Brand Name: BREASTPUMP PNSA STARTER
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA, INC.; 1101 coprorate dr; mchenry IL 60050
• Manufacturer (Section G): MEDELA, INC.; 1101 corporate dr; mchenry IL 60050
• Manufacturer Contact: robert sokolowski ; 1101 corporate drive; mchenry, IL 60050 ; 8155782220
• MDR Report Key: 5445695
• MDR Text Key: 38523930
• Report Number: 1419937-2016-00044
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 57081
• Device Catalogue Number: 57081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/05/2016
• Date Manufacturer Received: 04/13/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other