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 |