MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-01-10 for MGARD SOF-TRAY SHEETS (226) manufactured by Manufactured For Ultradent By Universal Plastics.
[1797495]
The adverse event occurred at a (b)(6) during a mfr-sponsored, hands-on lecture. During the tray fabrication exercise, a female (b)(6) became light-headed, flushed and felt like she was going to pass out. Four vacuum former machines were running at the time, and all were using tray sheets and lc blockout resin during this time. The fumes were noticeable in the room from these activities. The (b)(6) was taken to the clinical area and a wet rag placed on the back of her neck. Her heart was racing, so paramedics were called. The student's bp was 156/90 and her pulse was 116. The student was taken to (b)(6) and released in the evening. The on-call physician believes the reaction was caused by the fumes in the room. A week later, the student had a similar reaction while she was trimming trays (this is done after lc blockout resin and vacuum forming has been done). This reaction was less severe, but the student did leave class to purchase and take benadryl. The student felt fine 20 mins later.
Patient Sequence No: 1, Text Type: D, B5
[8924577]
The lc blockout resin ifu contains a precaution/warning about the potential for sensitization when handling methacrylate-based resins, and mentions 'if allergic reaction, dermatitis or rash develops, consult a physician. '
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718912-2011-00001 |
| MDR Report Key | 1960298 |
| Report Source | 99 |
| Date Received | 2011-01-10 |
| Date of Report | 2011-01-07 |
| Date of Event | 2010-12-03 |
| Date Mfgr Received | 2010-12-17 |
| Date Added to Maude | 2012-04-27 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MGARD SOF-TRAY SHEETS (226) |
| Generic Name | SOF-TRAY CLASSIC SHEETS (0.035") |
| Product Code | BRW |
| Date Received | 2011-01-10 |
| Model Number | 226 |
| Catalog Number | 226 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MANUFACTURED FOR ULTRADENT BY UNIVERSAL PLASTICS |
| Manufacturer Address | 2650 E 40TH AVENUE DENVER CO 80205 US 80205 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-01-10 |