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

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

Patient Problems Cyst(s) (1800); Granuloma (1876); Failure of Implant (1924); Inflammation (1932); Urinary Tract Infection (2120); Regurgitation (2259)

Event Type  Injury  

Event Description

A physician reported via a literature article that (b)(6) female received deflux (dextranomer microspheres/hyaluronic acid) injection into the submucosa of the urinary bladder as treatment for bilateral grade 2 vesicoureteral reflux (vur).Additional medical history included recurrent urinary tract infections.Concurrent medications were not provided.On unknown date, the patient received deflux.Three years after deflux, recurrent urinary tract infections persisted.In addition, a miction cystography revealed the presence of second-degree vur on the right and third-degree vur on the left.On unknown date, the patient underwent a bilateral re-implantation of the ureters by foure method.Intraoperative findings were: hard inflammatory infiltrates around the paraureteral segments of both ureters, a palpable lump on the wall of the left ureter, and granulomas of the urinary bladder wall at the vesical ostia.Histopathology revealed a chronic inflammatory lymphocytic infiltrate around both fragments of the resected ureters with a cluster of a substance of iatrogenic origin surrounded by polynucleic histiocytes located outside the muscular coat.The granulomas that were removed from the urinary bladder wall contained the muscular coat of the bladder with pseudocysts filled with a substance of iatrogenic origin, as well as amorphic calcifications, calcified eosinophilic necrotic masses, and clusters of histiocytes.The lump from the wall of the left ureter was a similar pseudocyst with a band of polynucleic histiocytes visible on its internal layer and externally surrounded by a band of the fibrous connective tissue.Postoperatively, the urinary tract infections resolved.Six months later, a miction cystography was performed and did not show the presence of vur.In addition, the scintigraphic picture of both kidneys one year after the operation was normal.The authors felt that the events were related to deflux.The company felt the events were related to deflux.Zyckowski, m."complications following endoscopic treatment of vesicoureteric reflux with deflux-two case studies." central european journal of urology, 65.4 (2012) : 230-231.

• 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: 3708614
• MDR Text Key: 4266485
• Report Number: 3009325614-2014-00013
• 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
• Device Age: 3 YR
• 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: 8 YR