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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Obstruction/Occlusion (2422); Abdominal Distention (2601)

Event Date 08/22/2014

Event Type  Injury  

Event Description

A physician reported that a (b)(6)y/o female received deflux (dextranomer microspheres/hyaluronic acid) injection into the submucosa of the urinary bladder as treatment for grade 4 vesicoureteral reflux on the left and grade 2/3 reflux on the right.Add'l medical history and concurrent medications were not provided.On (b)(6) 2014, the pt received deflux.She was injected with 0.8 cc on each side.The day after deflux insertion, the pt was doing well according to her mother.On (b)(6) 2014, the pt underwent a renal ultrasound as routine f/u to the procedure.The ultrasound showed severe left hydronephrosis grade 4 dilatation and moderate hydroureter extending down to 1.5 cm deflux injection site mass protruding into the bladder at the left vesicoureteral insertion.The pt's right side was normal.On (b)(6) 2014, the pt was evaluated by the physician.On (b)(6) 2014, the pt was scheduled to undergo a cystoscopy and left stent placement.The physician felt the events were possibly related to deflux.The company assessed the events as possibly related to deflux.

Manufacturer Narrative

Based on the info received, a causality seems possible.

• Brand Name: DEFLUX
• Type of Device: AGENT, BULKING, INJECTABLE
• Manufacturer (Section D): Q-MED AS; uppsala ; SW
• Manufacturer Contact: 8510 colonnade center dr; raleigh, NC 27615 ; 9198621000
• MDR Report Key: 4129603
• MDR Text Key: 20863816
• Report Number: 3009325614-2014-00043
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2014,08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2014
• 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: 09/08/2014
• Distributor Facility Aware Date: 08/22/2014
• Date Report to Manufacturer: 09/03/2014
• Date Manufacturer Received: 08/22/2014
• 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