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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

A physician reported via a sales representative that an (b)(6) year old male received deflux (dextranomer microspheres/hyaluronic acid) injection into the submucosa of the urinary bladder as treatment for vesicoureteral reflux.Additional medical history and concomitant medications were not provided.On (b)(6) 2014, the patient received deflux via the double-hit technique, injecting 1.8 cc into the right ureteral orifice.On an unknown date, the patient experienced ureterovesical junction obstruction.On (b)(6) 2014, stent placement was performed to correct the obstruction.At the time of this report, the patient remained in the hospital with the event improved, but still present.Causality was not provided.The company felt the event was possibly related to deflux.

Manufacturer Narrative

The event is possibly related to the treatment with deflux.

• 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 7522 28; SW 752228
• Manufacturer Contact: 8510 colonnade center dr; raleigh, NC 27615-0000 ; 9198621000
• MDR Report Key: 4168341
• MDR Text Key: 5087081
• Report Number: 3009325614-2014-00049
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/08/2014,09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• 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: 10/08/2014
• Distributor Facility Aware Date: 09/19/2014
• Date Report to Manufacturer: 09/24/2014
• Date Manufacturer Received: 09/19/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 11 YR
• Patient Weight: 44