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

Lot Number 11149-1

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body Reaction (1868); Granuloma (1876); Urinary Tract Infection (2120)

Event Date 12/07/2013

Event Type  Injury  

Event Description

A physician reported that a (b)(6) female received deflux (dextranomer microspheres/hyaluronic acid) injection into the submucosa of the urinary bladder as treatment for vesicoureteral reflux.Additional medical history included recurrent urinary infections from the age of (b)(6) and left ureteral duplication.Concurrent medications were not provided.On (b)(6) 2012, the patient underwent a cystoscopy and deflux was injected into the right and left ureteral opening using the sting technique.Both sides received an injection of 0.5 ml.On unknown date, the patient began experiencing repeated urinary test infections.On (b)(6) 2013, an abdominal ultrasound was performed and showed a well-defined, hyperechogenic bladder mass (14/12 mm) situated near the right ureteral opening.On (b)(6) 2013, an exploratory cystoscopy was performed and the presence of the mass was confirmed.On (b)(6) 2013, a cystography was done showing bilateral vesicoureteral reflux and a filling defect measuring 2/1 cm.On (b)(6) 2013, the "tumor" (injection site granuloma) was resected.The biopsy of the resected mass showed modifications suggestive for an inflammatory reaction to a foreign body.The material showed no tumor structures benign or malignant.The patient was recovering from the events at the time of this report.The physician felt the events were serious and possibly related to deflux.Report received from (b)(6).

Manufacturer Narrative

A causality seems possible.No corrective action will be initiated.No trend is noticed for this specific batch (this is the first complaint received for this batch).

• 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: 3677037
• MDR Text Key: 4258743
• Report Number: 3009325614-2014-00007
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: P000029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2014,02/07/2014

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
• Device Lot Number: 11149-1
• 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: 02/25/2014
• Distributor Facility Aware Date: 02/07/2014
• Date Report to Manufacturer: 02/25/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2014
• 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: 5 YR