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

Model Number GEL 1.0 ML SYRINGE

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2022

Event Type  malfunction  

Event Description

Preparing for a cystoscopy w/pic cystogram & bilateral delfux.The doctor pushed on the plunger of the deflux injectable gel and the barrel flange broke off.This happened twice before being able to continue.

• Brand Name: DEFLUX
• Type of Device: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): PALETTE LIFE SCIENCES, INC.; 27 east cota; santa barbara CA 93101
• MDR Report Key: 16093939
• MDR Text Key: 306608170
• Report Number: 16093939
• Device Sequence Number: 1
• Product Code: LNM
• UDI-Device Identifier: 00850004725009
• UDI-Public: 0100850004725009
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2022,11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GEL 1.0 ML SYRINGE
• Device Catalogue Number: 241296
• Device Lot Number: 18659
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2022
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 01/04/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1