MAUDE Adverse Event Report: BAUSCH + LOMB DEFLUX INJECTABLE GEL; AGENT,BULKING,INJECTABLE FOR GASTRO-UROLOGY USE

Model Number DEFLUX

Device Problem Calcified (1077)

Patient Problems Calcium Deposits/Calcification (1758); Pain (1994); Urinary Frequency (2275); Dysuria (2684)

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is in progress.A follow-up report will be submitted upon completion of the investigation.

Event Description

Published article titled "a case of dextranomer-hyaluronic acid copolymer (deflux®) implants calcification mimicking distal ureteral calculi" reports a case of deflux implants calcification mimicking distal ureteral calculi in a patient with a history of deflux injection performed 9 years prior for primary vesicoureteral reflux (vur).Additional information has been requested, but no additional information has been received.

Event Description

Endoscopic reflux surgery using deflux was performed when the patient was (b)(6).A total of 0.8 ml of deflux was injected under the submucosa of the right ureteral orifice.There was nothing in particular to be noted in the postoperative course including upper urinary tract dilation, and disappearance of vur was confirmed by cystourethrography during urination at the 3rd month and the 1st year.Afterwards, no urinary tract infection was observed, and a final examination was conducted.When the patient was (b)(6), he was admitted to a nearby hospital with a chief complaint of frequent urination, pain on urination and a feeling of residual urine.Although there were no abnormalities in the findings from the urine, ultrasonography revealed a shadow accompanied by an acoustic shadow at the bottom of the right bladder, and ureteral calculi were suspected.There was no hydronephrosis or hydroureter.Although the symptoms disappeared spontaneously after that, the patient was admitted.As a result of comparison with past records, the shadow that was thought to be ureteral calculi was consistent with the deflux implant from the results of repeated ultrasound examinations.Currently, the patient is (b)(6) and no recurrence of symptoms has been observed.In addition, although renal function is being followed up, the patient is stable at ckd stage 2.

Manufacturer Narrative

Investigation of this event is in progress.A follow-up report will be submitted upon completion of the investigation.

Manufacturer Narrative

Additional information: manufacturer name, city and state, mfr site, if follow-up, what type.The lot number of the device was not provided and the device was not returned for evaluation.Therefore, a device history record (dhr) review and product evaluation could not be conducted.Based on the current information, the root cause of the event could not be conclusively determined.

• Brand Name: DEFLUX INJECTABLE GEL
• Type of Device: AGENT,BULKING,INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• MDR Report Key: 7304817
• MDR Text Key: 101237641
• Report Number: 3009443653-2018-00007
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): Y
• PMA/PMN Number: P000029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2018

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: No Information
• Device Model Number: DEFLUX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/28/2018
• Supplement Dates Manufacturer Received: 03/17/2018; 03/17/2018
• Supplement Dates FDA Received: 04/12/2018; 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 12 YR