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

Model Number 11827

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 05/01/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient passed away.The cause of death is unknown.

• Brand Name: PROMETRA PROGRAMMABLE PUMP
• Type of Device: IMPLANTABLE INFUSION PUMP
• Manufacturer (Section D): FLOWONIX MEDICAL, INC; 500 international drive; suite 200; mount olive NJ 07828
• Manufacturer Contact: karen matis ; 500 international drive; suite 200; mount olive, NJ 07828 ; 9734269229
• MDR Report Key: 8674294
• MDR Text Key: 147172825
• Report Number: 3010079947-2019-00079
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11827
• Device Catalogue Number: 11827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death