MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-03 for DYNA-FLEX * 300-020 manufactured by Ortho Organizers.
[16272512]
Rinsed excess gel etch from lower second molar. Either wetting cheek retractors or spatter caused gel etch contact w/lower lip. Causing hyperemic decornified "blemish". Pt referred to plastic surgeon. 2/11/97 follow-up grey appeared nearly normal, used tropical coltizone ointment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1010876 |
| MDR Report Key | 73142 |
| Date Received | 1997-03-03 |
| Date of Event | 1996-10-14 |
| Date Added to Maude | 1997-03-06 |
| 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 |
| 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 | DYNA-FLEX |
| Generic Name | CHEEK RETRACTOR |
| Product Code | EIG |
| Date Received | 1997-03-03 |
| Model Number | * |
| Catalog Number | 300-020 |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 72984 |
| Manufacturer | ORTHO ORGANIZERS |
| Manufacturer Address | 1619 S. RANCHO SANTA FE RD. SAN MARCOS CA 92069 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-03-03 |