MAUDE Adverse Event Report: MEDELA AG FREESTYLE HANDS-FREE BREASTPUMP; PUMP, BREAST, POWERED

Model Number	8107176/67060
Health Effect - Clinical Code	Rash (2033)
Date of Event	07/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Basic product not in retail packaging, including breast shields, was sent to the customer, who expressed concern over not also getting a cooler and pump bag.Multiple attempts to contact the customer to get additional information and to get product back were not responded to.Reported issues of rash were investigated under in (b)(4), which determined the root cause to be potential for the product, after it is opened, to come in contact with environmental allergens, lotions or creams, and cleaning solutions that may cause an allergic reaction or irritation.Such root cause is not a product malfunction or a deficiency in information available to the user.
Event or Problem Description
On (b)(6) 2017, the customer alleged that her freestyle breast pump was producing low suction.She refused to conduct troubleshooting.She was instructed to return the pump before a replacement would be sent to her.On (b)(6) 2017, the customer made a second contact, alleging that she was using the 27 mm breast shields with the freestyle pump and they caused a rash on her breasts, for which she saw a doctor and was given a cream.On (b)(6) 2017, the customer made a third contact, indicating that she sent her freestyle pump back.However, tracking information does not substantiate that claim.She indicated that the doctor gave her an antibiotic cream which she used for 2 weeks and she can use the pump again.She inquired about a replacement pump and was again instructed to return the original pump before a replacement would be sent.On (b)(6) 2017, the customer made a fourth contact and was escalated to a lead.The customer once again stated that she returned the pump; however, tracking information does not substantiate that claim.

• Brand Name: FREESTYLE HANDS-FREE BREASTPUMP
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ 6341
• MDR Report Key: 6770562
• Report Number: 1419937-2017-00220
• Device Sequence Number: 653511
• Product Code: HGX
• UDI-Device Identifier: 00020451670607
• UDI-Public: 0100020451670607
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K150499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2017

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
• Operator of Device: Lay User/Patient
• Device Model Number: 8107176/67060
• Device Catalogue Number: 8107176/67060
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 08/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other