MAUDE Adverse Event Report: BAUSCH + LOMB DUFLUX INJECTABLE GEL; AGENT, BULKING, INJECTABLE

Model Number DEFLUX

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

Patient Problems Obstruction/Occlusion (2422); Abdominal Distention (2601)

Event Type  Injury  

Manufacturer Narrative

Investigation is underway.A supplemental report will be submitted upon completion of the investigation.

Event Description

Published article titled "delayed-onset ureteral obstruction and calcification masquerading as renal colic following deflux° injection" reports a case of febrile renal colic 66 months after deflux injection for vesico-ureteral reflux.Radiography revealed left sided renal hydronephrosis and hyperechoic structures consistent with kidney stones but no stones were found on endoscopy.Patient was treated with 12 weeks of ureteral stenting and has remained stable after 2 years of follow up.

Manufacturer Narrative

Despite attempts to obtain additional information, no additional information was received.The device was not returned for evaluation; therefore, product evaluation could not be conducted.The lot number of the device was not provided; therefore, a device history record (dhr) review could not be performed.Based on the information available, the exact cause of the reported event could not be conclusively determined.

• Brand Name: DUFLUX INJECTABLE GEL
• Type of Device: AGENT, BULKING, INJECTABLE
• Manufacturer (Section D): BAUSCH + LOMB; raleigh, nc; rochester NY 14609
• Manufacturer (Section G): Q-MED; q-med, seminariegatan 21; uppsala 75228 ; SW 75228
• Manufacturer Contact: sharon spencer ; 50 technology drive west; irvine, CA 92618 ; 9493985698
• MDR Report Key: 5618552
• MDR Text Key: 43983684
• Report Number: 3009443653-2016-00005
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2016

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 Operator: Physician
• Device Model Number: DEFLUX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2016
• Initial Date FDA Received: 04/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2016
• 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): Other
• Patient Age: 8 YR