MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-03-05 for DIAPEX REF-1001-301 manufactured by Bisco, Inc..
[1073960]
In 2009, a report was received from a dentist that during a dental procedure, the dentist injected diapex into the pt's apex, and filled the "bone canal spaces and inferior alveolar nerve space. " a panorex, dated 2008, shows the presence of the material. The dentist states that the pt was referred to an oral surgeon, and that the pt "went through a resection of the bone around the apex of the tooth and the lateral bone had to be removed to expose the nerve. The nerve had to be teased out to gain access to the paste. " a medical update from the oral/maxillofacial surgeon, confirmed the pt "underwent nerve lateralization and removal of a foreign substance under iv sedation five days later".
Patient Sequence No: 1, Text Type: D, B5
[8219476]
This device is exclusively distributed and this is the first adverse occurence that has been reported to the mfr. We are unable to verify the procedural technique used by the healthcare practitioner; however, review of the directions for use, discuss the gradual application/withdrawal technique to be used, and the syringe contains visual markings to determine the amount dispensed during its application.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1420052-2009-00001 |
| MDR Report Key | 1335733 |
| Report Source | 05 |
| Date Received | 2009-03-05 |
| Date of Report | 2009-02-05 |
| Date of Event | 2009-11-01 |
| Date Mfgr Received | 2009-02-05 |
| Date Added to Maude | 2009-03-12 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | C. ORIS |
| Manufacturer Street | 1100 WEST IRVING PARK RD. |
| Manufacturer City | SCHAUMBURG IL 60193 |
| Manufacturer Country | US |
| Manufacturer Postal | 60193 |
| Manufacturer Phone | 8475346027 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAPEX |
| Generic Name | ROOT CANAL FILLING RESIN |
| Product Code | EBD |
| Date Received | 2009-03-05 |
| Model Number | REF-1001-301 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BISCO, INC. |
| Manufacturer Address | SCHAUMBURG IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-03-05 |