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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Pain (1994); 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) female received deflux (dextranomer microspheres/hyaluronic acid) injection into the submucosa of the urinary bladder as treatment for bilateral grade 2-3 vesicoureteral reflux (vur) and breakthrough infections.Additional medical history and concurrent medications were not provided.On an unk date, the pt received deflux, 0.7 ml to each side utilizing the subureteral transurethral injection technique (sting).Perioperative prophylaxis was given.A few hours after the injection, she complained of abdominal pain and medical attention was sought the following day for severe right flank pain.A color doppler ultrasound showed right hydroureteronephrosis and no urine jet at the right ureteric orifice.Because of increasing pain and dilatation on ultrasonography a percutaneous nephrostomy was placed 72 hours later.The urine culture grew proteus mirabilis and appropriate treatment was instituted.The nephrostomy fell out spontaneously 14 days later, and the pt remained free of symptoms thereafter.Two months later, ultrasound revealed resolution of the dilatation.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 possible related to deflux.

• Brand Name: DELFUX
• Type of Device: AGENT, BULKING, INJECTABLE
• Manufacturer (Section D): Q-MED AB; uppsala ; SW
• Manufacturer Contact: 8510 colonnade center dr; raleigh, NC 27615 ; 9198621000
• MDR Report Key: 4468395
• MDR Text Key: 5183020
• Report Number: 3009325614-2015-00004
• 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: 4 YR