MAUDE Adverse Event Report: FLOWONIX MEDICAL, INC. PROMETRA II PROGRAMMABLE PUMP; IMPLANTABLE INFUSION PUMP

Model Number	16827
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Erosion (2075)
Date of Event	03/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record, which includes verification of all steps in the manufacturing of the pump, verification of all final testing performed by/on the pump, verification of sterilization, and packaging for subject pump was performed.The review did not identify any non-conformances, issues or capas associated with pump function.Device was not returned.Per the instructions for use of the device, pump site skin erosion is a possible known risk of use of the device.Internal complaint number: (b)(4).
Event or Problem Description
Agent stated that the physician had opted to switch the patient from a 20ml to a 40ml to determine if the patient could 'tolerate' the larger pump for the benefits of the larger reservoir.The patient reportedly had a pimple at the pump site that got infected in addition to 'terrible skin breakdown' issues.As a result, the physician opted to switch back to the 20ml pump.Agent confirmed that the physician did not allege any issue with the pump itself.The replaced pump will not be returned.

• Brand Name: PROMETRA II PROGRAMMABLE PUMP
• Common Device Name: IMPLANTABLE INFUSION PUMP
• Manufacturer (Section D): FLOWONIX MEDICAL, INC.; 500 international drive; suite 200; mount olive NJ 07828
• MDR Report Key: 11694335
• Report Number: 3010079947-2021-00114
• Device Sequence Number: 3515233
• Product Code: LKK
• UDI-Device Identifier: 00810335020242
• UDI-Public: (01)00810335020242(10)27159(17)211110
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2021

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: Health Professional
• Device Expiration Date: 11/10/2021
• Device Model Number: 16827
• Device Catalogue Number: 16827
• Device Lot Number: 27159
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/20/2021
• 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: Required Intervention