MAUDE Adverse Event Report: BAUSCH + LOMB DEFLUX INJECTABLE GEL; AGENT,BULKING,INJECTABLE FOR GASTRO-UROLOGY USE

Model Number DEFLUX INJECTABLE GEL

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

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is in progress.A follow-up report will be submitted upon completion of the investigation.

Event Description

A published article titled "delayed ureteric obstruction occured 4 years after deflux injection" reports a case of ureteral obstruction approximately 4 years post-injection.The presence of bilateral vesicoureteral reflux (vur) was found on a young boy following the onset of febrile urinary tract infection (uti) at the age of 4 months via voiding cystourethrogram (vcug).Uti did not recur after starting prophylactic sulfamethoxazole-trimethoprim.The patient was referred to our clinic because the exam showed no right vur but also no improvement of left vur at the age of 1 year.Grade 1 to 2 left hydronephrosis was found during the initial consultation.The patient had been followed conservatively until he turned (b)(6).Because the left vur did not improve, a deflux injection was given upon request from the parents.Severe hydraulic expansion of the left ureteral orifice was reversed with deflux 0.8 ml injected by using the hydrodistention-implantation technique (hit) and 1 ml injected by using the subureteric transurethral injection (sting).The patient had no pain or did not vomit after surgery.The ultrasound performed immediately after surgery showed left hydronephrosis was still grade 1 as it had been pre-operation; however, it disappeared 1 month after surgery.The vcug examinations performed at 3 months and 14 months after surgery showed no left vur.Grade 1 left hydronephrosis was found during the periodic follow-up examination at the age of 7 years.Four months later, it was slightly exacerbated to grade 2.Grade 3 left hydroureteronephrosis was found 6 months later.Upon examination, the deflux material was visible on the bladder wall; however, the volume was not significantly changed compared with 1 month after surgery.Renogram test (ri) showed no decrease of split renal function.Additional event information for this event has been requested.

Manufacturer Narrative

The device was not returned.A device lot number was not reported, so a device history record (dhr) review could not be performed.Based on the available information, a root cause for the reported event could not be conclusively determined.

• Brand Name: DEFLUX INJECTABLE GEL
• Type of Device: AGENT,BULKING,INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• MDR Report Key: 7987152
• MDR Text Key: 124490834
• Report Number: 3009443653-2018-00020
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): Y
• PMA/PMN Number: P000029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DEFLUX INJECTABLE GEL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other