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 Problems Death (1802); Erythema (1840); Hemorrhage/Bleeding (1888); Pain (1994); Raynauds Phenomenon (2034); Obstruction/Occlusion (2422)

Event Type  Death  

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 "deterioration of autoimmune condition associated with repeated injection of dextranomer/hyaluronic acid copolymer: a case report" reports a diagnosed case of ureteral stenosis approximately 2 years after injection.A (b)(6)-year old female patient underwent endoscopic deflux injection (edi) for the treatment of bilateral vur of grade 2.Another edi was performed because cystourethrogram at 3 months post-operative showed a persistent left vur of grade 2.One and a half years after, she claimed left flank pain.Ultrasound examination showed left hydronephrosis hydroureter, and delayed excretion from the left kidney was observed by mag3.Delayed onset of ureteral stenosis was diagnosed, and a ureteral stent was placed.She also presented with erythema on both cheeks and raynaud¿s phenomenon; autoimmune disease was suspected.Since a relationship with the autoimmune disease was also suspected, a risk of developing a heterochronic right ureteral stenosis was concerned, and ureterocystoneostomy (ucn) on both sides was performed, with satisfactory postoperative course.Significant infiltration of eosinophil to the area of ureteral stenosis was observed histopathologically, and the patient died of pulmonary hemorrhage due to thrombotic thrombocytopenic purpura 4 months after ucn.Reactive stenosis accompanied by allergy was suggested in this case.It was considered that the treatment of edi should be discussed more carefully to a patient who predisposes to allergies.

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
• Manufacturer (Section G): Q-MED; seminariegatan 21; uppsala SE-75 2 28; SW SE-752 28
• Manufacturer Contact: tes proud ; 1400 north goodman street; rochester, NY 14609 ; 5853388549
• MDR Report Key: 7346980
• MDR Text Key: 102703588
• Report Number: 3009443653-2018-00009
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P000029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Model Number: DEFLUX INJECTABLE GEL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 8 YR