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

Model Number 011504

Device Problem Off-Label Use (1494)

Patient Problems Headache (1880); Unspecified Infection (1930); Necrosis (1971); Numbness (2415); No Code Available (3191)

Event Date 01/19/2019

Event Type  Injury  

Manufacturer Narrative

Deflux is approved for the treatment of children with vesicoureteral reflex (vur) grades ii-iv.This procedure for velopharyngeal insufficiency is an off-label procedure.The labeling for deflux states, "deflux is to be administered only by qualified surgeons experienced in the use of a cystoscope and trained in the technique of subureteric and/or interureteric injections (with deflux or other materials)".This procedure was not subureteric and/or interureteric.In addition, it appears the patient had a preexisting metal pharyngeal implant for sleep apnea jaw surgery, which increases the risk of infection.

Event Description

Patient underwent a procedure where the deflux was injected into the patient's soft palette, which is an off-label use of product.The patient had previously undergone plating of her jaw for sleep apnea.The patient presented with an infection of the lower jaw and stated that it may be related to the prior sleep apnea jaw surgery.The patient was treated with antibiotics for the bone infection, removal of the metal plates, and debridement of necrotic bone and tissue.The patient also complained of headaches and numbness in her face.This is the same patient/ event reported in medwatch #9710154-2020-00012.

• Brand Name: DEFLUX
• Type of Device: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): PALETTE LIFE SCIENCES; 27 e. cota street; santa barbara CA 93101
• Manufacturer (Section G): PALETTE LIFE SCIENCES; 27 e. cota street; santa barbara CA 93101
• Manufacturer Contact: cliff kline ; 27 e. cota street; santa barbara, CA 93101 ; 8058697056
• MDR Report Key: 9667333
• MDR Text Key: 177799206
• Report Number: 3014909464-2020-00001
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 011504
• Was Device Available for Evaluation?: No
• 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 Outcome(s): Hospitalization
• Patient Age: 52 YR