MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-03-16 for DEFLUX INJECTABLE GEL manufactured by Bausch + Lomb.
[102703588]
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
[102703589]
A published article titled "deterioration of autoimmune condition associated with repeated injection of dextranomer/hyaluronic acid copolymer: a case report" reports a diagnosed case of ureteral stenosis approximately 2 years after injection. A (b)(6)-year old female patient underwent endoscopic deflux injection (edi) for the treatment of bilateral vur of grade 2. Another edi was performed because cystourethrogram at 3 months post-operative showed a persistent left vur of grade 2. One and a half years after, she claimed left flank pain. Ultrasound examination showed left hydronephrosis hydroureter, and delayed excretion from the left kidney was observed by mag3. Delayed onset of ureteral stenosis was diagnosed, and a ureteral stent was placed. She also presented with erythema on both cheeks and raynaud? S phenomenon; autoimmune disease was suspected. Since a relationship with the autoimmune disease was also suspected, a risk of developing a heterochronic right ureteral stenosis was concerned, and ureterocystoneostomy (ucn) on both sides was performed, with satisfactory postoperative course. Significant infiltration of eosinophil to the area of ureteral stenosis was observed histopathologically, and the patient died of pulmonary hemorrhage due to thrombotic thrombocytopenic purpura 4 months after ucn. Reactive stenosis accompanied by allergy was suggested in this case. It was considered that the treatment of edi should be discussed more carefully to a patient who predisposes to allergies.
Patient Sequence No: 1, Text Type: D, B5
[119379817]
The device was not returned. A device lot number was not reported, so a device history record (dhr) review could not be performed. Based on the available information, a root cause for the reported event could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009443653-2018-00009 |
| MDR Report Key | 7346980 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2018-03-16 |
| Date of Report | 2018-02-22 |
| Date Mfgr Received | 2018-02-22 |
| Date Added to Maude | 2018-03-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 2018-03-16 |
| Model Number | DEFLUX INJECTABLE GEL |
| ID Number | NI |
| Operator | PHYSICIAN |
| 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. Death; 2. Required No Informationntervention | 2018-03-16 |