MAUDE Adverse Event Report: PALETTE LIFE SCIENCES DEFLUX INJECTABLE GE; DEFLUIX

Model Number 011503

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

Adverse event occurred in a female pediatric patient 6 years post deflux endoscopic injection for correction of vur bilaterally.Symptoms included abdominal pain, ureteral enlargement of the left-side, and signs of left side ureteric obstruction.The right-side ureter and kidney were normal.The patient was taken to the operating room for correction of the left ureteric obstruction and oreteral reimplantation left side.Intra-operatively, the deflux bleb looked normal on the left side however, there was clear inflammation on the left ureter with left ureter dilation.Ride side ureter and deflux bleb were normal with no signs of inflammation and right-side was not reimplanted.Left-side ureter reimplantation was successul and the patient is doing well now.

• Brand Name: DEFLUX INJECTABLE GE
• Type of Device: DEFLUIX
• Manufacturer (Section D): PALETTE LIFE SCIENCES; 27 e cota st; suite 402; santa barbara CA 93101
• Manufacturer (Section G): PALETTE LIFE SCIENCES; 27 e cota st; suite 402; santa barbara CA 93101
• Manufacturer Contact: david goodnough ; 27 e cota st; suite 402; santa barbara, CA 93101 ; 8058697087
• MDR Report Key: 17344526
• MDR Text Key: 319348752
• Report Number: 3014909464-2023-00002
• Device Sequence Number: 1
• Product Code: LNM
• UDI-Device Identifier: 00850004725009
• UDI-Public: 00850004725009
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000029
• 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: 07/18/2023

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
• Device Model Number: 011503
• Device Catalogue Number: 011504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White