MAUDE Adverse Event Report: MEDELA LLC PNSA PUMP STARTER 1CT PT-A EN ES; PUMP, BREAST, POWERED

Model Number	101035077
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer was sent a replacement pump and return of her original pump was requested for testing/evaluation.In follow up with the complaint handler on 9/27/2022, the customer stated that she got a prescription burn cream and ibuprofen for pain.In additional follow up with the customer she stated that she received a first degree burn and is healing.Medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed).
Event or Problem Description
On (b)(6) 2022, the customer alleged to medela llc that she fell asleep while using her pump in style breast pump and the cord that connects to the pump came loose and burned her one breast and leg.Additionally she alleged that she is going to the emergency room.

• Brand Name: PNSA PUMP STARTER 1CT PT-A EN ES
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• Manufacturer Contact: dave kurudza ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 15667944
• Report Number: 1419937-2022-00083
• Device Sequence Number: 17936675
• Product Code: HGX
• UDI-Device Identifier: 00020451350776
• UDI-Public: 020451350776
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K181937
• 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): 10/25/2022

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: 101035077
• Device Catalogue Number: 101035077
• Device Lot Number: 453759
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/27/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female