MAUDE Adverse Event Report: PALETTE LIFE SCIENCES DEFLUX; AGENT, BULKING INJERCTABLE FOR GASTRO-UROLOGY USE - DEFLUX INJECTABLE GEL

Model Number 011504

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Renal Impairment (4499)

Event Type  Injury  

Event Description

Patient had an abdominal ultrasound.Obtained for abdominal fullness and was incidentally noted to have severe left hydroureteronephrosis.Prior to the study, she had no evidence of recurrent utis or obstructive urinary.Symptoms.Dedicated renal ultrasound demonstrated society of fetal urology (sfu) grade 4 hydronephrosis and a 1.4cm echogenic focus at the left uvj concerning for a calculus.(figure 1 and 2).Mag3 renal scan with lasix showed obstructive parameters on the left, and differential renal function of 15% left and 85% right (figure 3).Serum creatinine was 0.76 (egfr 63), and cystatin c was 1.1.

• Brand Name: DEFLUX
• Type of Device: AGENT, BULKING INJERCTABLE FOR GASTRO-UROLOGY USE - DEFLUX INJECTABLE GEL
• 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: 16541377
• MDR Text Key: 311290593
• Report Number: 3014909464-2023-00001
• 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: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 011504
• Device Catalogue Number: 011504
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 11 YR
• Patient Sex: Female