MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-09-30 for OPTRAGATE 590851AN manufactured by Ivoclar Vivadent Ag.
[20630671]
Dentist describes that he used an optragate to isolate an adult to place a bonded retainer from #22-27. The pt called back the next day to report that her lips, chin and nose were numb. No anesthetic was used. Dentist reports numbness has continued for 2 weeks as of date of this report and pt believes is spreading now to her nose and cheeks. The pt is a (b)(6) female with possible latex allergy. Nitrile exam gloves were used. The optragate does not contain latex.
Patient Sequence No: 1, Text Type: D, B5
[20707175]
Because it is unclear whether numbness is permanent, manufacturer has chosen to report as adverse incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612352-2010-00002 |
| MDR Report Key | 1870101 |
| Report Source | 05 |
| Date Received | 2010-09-30 |
| Date of Report | 2010-09-28 |
| Date of Event | 2010-09-23 |
| Date Mfgr Received | 2010-09-23 |
| Date Added to Maude | 2010-10-21 |
| 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 Street | 175 PINEVIEW DR |
| Manufacturer City | AMHERST NY 14228 |
| Manufacturer Country | US |
| Manufacturer Postal | 14228 |
| Manufacturer Phone | 7166912260 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTRAGATE |
| Generic Name | CHEEK RETRACTOR |
| Product Code | EIG |
| Date Received | 2010-09-30 |
| Catalog Number | 590851AN |
| Lot Number | ML5508 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IVOCLAR VIVADENT AG |
| Manufacturer Address | SCHAAN LS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2010-09-30 |