MAUDE Adverse Event Report: Q-MED AB DEFLUX; AGENT, BULKING, INJECTABLE

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Granuloma (1876); Failure of Implant (1924); Inflammation (1932); Urinary Tract Infection (2120); Regurgitation (2259)

Event Date 01/01/2005

Event Type  Injury  

Event Description

A physician reported via a literature article that a (b)(6) old female received deflux (dextranomer microspheres/hyaluronic acid) injection into the submucosa of the urinary bladder as treatment for left-sided grade 3 vesicoureteral reflux (vur).Additional medical history included recurrent urinary tract infections.Concurrent medications were not provided.In 2005, the patient received deflux into the vesical ostium of the left ureter.Following the procedure, the patient experienced persistent urinary tract infection.Three years after deflux implantation, a miction cystography revealed the presence of left-sided fifth-degree vur.On unknown date, the patient underwent re-implantation of the ureter.After opening the bladder, a hard inflammatory infiltrate in the area of the vesical ostium was found.Histopathology of the 2 centimeter ureteral segment revealed a significantly exfoliated transitional epithelium with a visible chronic inflammatory infiltrate beneath.Outside the muscular coat, a focus 2-millimeters in diameter was visible.It was formed by droplets of iatrogenic origin and surrounded by polynucleic histiocytes.Following surgery, the urinary tract infections resolved.Six months later, a miction cystography were performed and did not show any features of reflux.The authors felt that the events were related to deflux.The company felt the events were related to deflux.Source of report (literature): 1, marcin zyczkowski, central european journal of urology, 2012, 65, from 230 to 231, complications following endoscopic treatment of vesicoureteric reflux with deflux-two case studies.

• Brand Name: DEFLUX
• Type of Device: AGENT, BULKING, INJECTABLE
• Manufacturer (Section D): Q-MED AB; uppsala ; SW
• Manufacturer (Section G): Q-MED AB; seminariegatan 21; uppsala SE-7 52 2; SW SE-752 28
• Manufacturer Contact: 8510 colonnade center dr; raleigh, NC 27615 ; 9198621000
• MDR Report Key: 3708613
• MDR Text Key: 16058809
• Report Number: 3009325614-2014-00010
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P000029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2014,03/04/2014

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2014
• Distributor Facility Aware Date: 03/04/2014
• Date Report to Manufacturer: 03/14/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2014
• 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): Required Intervention
• Patient Age: 3 YR