MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-10-21 for ACRYLIC RESIN manufactured by 3m Co..
[12969]
Dentist used an acrylic resin to fill cavities below the gum line. Resin containes "milacsic acid. " resin can only be desolved by ethynol gasoline. However the acid from foods can make resin soft. When resin becomes soft, it can move. Pt says the resin in her mouth has moved into her sinus and towards her eye. Pt says food acids can disolve the "milacsic" acid from the resin which is a health hazard.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000590 |
| MDR Report Key | 18339 |
| Date Received | 1994-10-21 |
| Date of Report | 1994-10-21 |
| Date Added to Maude | 1994-12-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACRYLIC RESIN |
| Product Code | EBD |
| Date Received | 1994-10-21 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 18267 |
| Manufacturer | 3M CO. |
| Manufacturer Address | ST PAUL MN 55144 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-10-21 |