MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-10-18 for ENDOREZ CANAL SEALER 5900 manufactured by Ultradent Products.
[2248069]
Dr (b)(6) is a oral maxillofacial surgeon. He reported the pt also reported pain. He told dr (b)(6), ultradent's in-house dentist, he had not done anything to the pt. He wanted info on endorez. Dr (b)(6) explained that it was a udma resin and gave a little history on them as bone cements. Dr (b)(6) told him not to invasively try to remove the chemical as this would quite possibly cause more nerve damage, he agreed. Dr (b)(6) explained the immune mechanism of foreign body phagocytosis that would bio-absorb this material over months to a few years and that the symptoms should slowly resolve with time. Dr (b)(6) advised that he should f/u at 6 month intervals at first and go from there. The pt was referred to dr (b)(6) by dr (b)(6), who called and explained what happened at the time of injury. He was back filling the canal and some of the endorez went inside the canal space. They caught it immediately after on the pa. Right after the pt was asymptomatic and after 2 days started having some inflammation and the numbness had not gone away. That is when he referred the pt to dr (b)(6). No other adverse effects other than the numbness.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718912-2011-00007 |
| MDR Report Key | 2305999 |
| Report Source | 05 |
| Date Received | 2011-10-18 |
| Date of Report | 2011-10-18 |
| Date of Event | 2011-09-22 |
| Date Mfgr Received | 2011-09-22 |
| Device Manufacturer Date | 2011-07-01 |
| Date Added to Maude | 2012-07-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 10200 505 WEST |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOREZ CANAL SEALER |
| Generic Name | ENDODONTIC FILLER & SEALER |
| Product Code | EBC |
| Date Received | 2011-10-18 |
| Model Number | 5900 |
| Catalog Number | 5900 |
| Lot Number | B76WX |
| Device Expiration Date | 2012-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTRADENT PRODUCTS |
| Manufacturer Address | 10200 505 W SOUTH JORDAN UT 84095 US 84095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-10-18 |