MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-04-29 for LATEX RUBBER DAM manufactured by Unknown.
[21623357]
7/95 rptr had root canal dental work with rubber dam resulting in severe swelling of throat and eyes. (also see 1008971)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1008993 |
| MDR Report Key | 32429 |
| Date Received | 1996-04-29 |
| Date of Report | 1996-04-22 |
| Date of Event | 1993-01-01 |
| Date Added to Maude | 1996-05-03 |
| 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 | LATEX RUBBER DAM |
| Generic Name | RUBBER DAM |
| Product Code | EIE |
| Date Received | 1996-04-29 |
| Operator | OTHER |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 33706 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 1996-04-29 |