MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-02-28 for DEFLUX INJECTABLE GEL manufactured by Bausch + Lomb.
[101237641]
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
[101237642]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009443653-2018-00007 |
| MDR Report Key | 7304817 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2018-02-28 |
| Date of Report | 2018-01-30 |
| Date Mfgr Received | 2018-03-17 |
| Date Added to Maude | 2018-02-28 |
| 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 75228 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 75228 |
| 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 | 2018-02-28 |
| Model Number | DEFLUX |
| ID Number | NI |
| 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 | 2018-02-28 |