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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Urinary Tract Infection (2120); Obstruction/Occlusion (2422); Abdominal Distention (2601)

Event Type  Injury  

Event Description

A physician reported via a literature article pertaining to a retrospective chart review that a (b)(6) male received deflux (dextranomer microspheres/hyaluronic acid) injection into the submucosa of the urinary bladder as treatment for left grade 1 vesicoureteral reflux (vur).Additional medical history included vacterl association with a crossed ectopic solitary left kidney, febrile urinary tract infections (utis), and a diverticulum medial to the orifice.Concomitant medications were not provided.On an unk date, the pt received deflux, 2 x 0.6 ml (1.2 ml total) utilizing the subureteral transurethral injection technique (sting).Perioperative prophylaxis and antibiotic prophylaxis for four weeks was given.No symptoms occurred, but a routine ultrasound 6 weeks later showed mild to moderate hydroureteronephrosis.At that time, no specific treatment was initiated.In the following 3 months, the pt had two utis and hydroureteronephrosis persisted on ultrasound.An open ureterocystoneostomy (cohen) was performed.Postoperative ultrasound 4 and 22 months later showed markedly decreased hydronephrosis.The authors concluded that the incidence of ureteral obstruction complication was higher than previously reported in the literature.Report received from q-med.The company assessed the events as possibly related to 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 SE-7 52 2; SW SE-752 28
• Manufacturer Contact: 8510 colonnade center drive; raleigh, NC 27615 ; 9198621000
• MDR Report Key: 4468396
• MDR Text Key: 18025952
• Report Number: 3009325614-2015-00005
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P000029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2015,01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2015
• 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: 01/28/2015
• Distributor Facility Aware Date: 01/08/2015
• Date Report to Manufacturer: 01/20/2015
• Date Manufacturer Received: 01/08/2015
• 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