MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-10-19 for DEFLUX INJECTABLE GEL manufactured by Bausch + Lomb.
[124490834]
Investigation of this event is in progress. A follow-up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[124490835]
A published article titled "delayed ureteric obstruction occured 4 years after deflux injection" reports a case of ureteral obstruction approximately 4 years post-injection. The presence of bilateral vesicoureteral reflux (vur) was found on a young boy following the onset of febrile urinary tract infection (uti) at the age of 4 months via voiding cystourethrogram (vcug). Uti did not recur after starting prophylactic sulfamethoxazole-trimethoprim. The patient was referred to our clinic because the exam showed no right vur but also no improvement of left vur at the age of 1 year. Grade 1 to 2 left hydronephrosis was found during the initial consultation. The patient had been followed conservatively until he turned (b)(6). Because the left vur did not improve, a deflux injection was given upon request from the parents. Severe hydraulic expansion of the left ureteral orifice was reversed with deflux 0. 8 ml injected by using the hydrodistention-implantation technique (hit) and 1 ml injected by using the subureteric transurethral injection (sting). The patient had no pain or did not vomit after surgery. The ultrasound performed immediately after surgery showed left hydronephrosis was still grade 1 as it had been pre-operation; however, it disappeared 1 month after surgery. The vcug examinations performed at 3 months and 14 months after surgery showed no left vur. Grade 1 left hydronephrosis was found during the periodic follow-up examination at the age of 7 years. Four months later, it was slightly exacerbated to grade 2. Grade 3 left hydroureteronephrosis was found 6 months later. Upon examination, the deflux material was visible on the bladder wall; however, the volume was not significantly changed compared with 1 month after surgery. Renogram test (ri) showed no decrease of split renal function. Additional event information for this event has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009443653-2018-00020 |
| MDR Report Key | 7987152 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2018-10-19 |
| Date of Report | 2017-06-30 |
| Date Added to Maude | 2018-10-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. TES PROUD |
| Manufacturer Street | 1400 NORTH GOODMAN STREET |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853388549 |
| Manufacturer G1 | Q-MED |
| Manufacturer Street | SEMINARIEGATAN 21 |
| Manufacturer City | UPPSALA SE-752 28 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-752 28 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEFLUX INJECTABLE GEL |
| Generic Name | AGENT,BULKING,INJECTABLE FOR GASTRO-UROLOGY USE |
| Product Code | LNM |
| Date Received | 2018-10-19 |
| Model Number | DEFLUX INJECTABLE GEL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | 1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-19 |