MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-10-27 for ENAHNCE CUP POLISHER UNK manufactured by Dentsply Int'l..
[101440]
Rptr was having a dental procedure done, when she experienced an adverse reaction to the latex polisher. The reaction included swelling of the eyes and throat. Pt was taken to the er and given an epinephrine shot. She experienced a type i reaction. Rptr now carries an epi-pen everywhere.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012361 |
| MDR Report Key | 128427 |
| Date Received | 1997-10-27 |
| Date of Report | 1997-10-27 |
| Date of Event | 1997-09-04 |
| Date Added to Maude | 1997-10-29 |
| 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 | ENAHNCE CUP POLISHER |
| Generic Name | CUP PROBLEM |
| Product Code | ECB |
| Date Received | 1997-10-27 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 125646 |
| Manufacturer | DENTSPLY INT'L. |
| Manufacturer Address | 500 W. COLLEGE AVE. YORK PA 17405 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1997-10-27 |