MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-04-02 for RUBBER DAM manufactured by Unknown.
[19731]
Rptr was teaching sterile technique to nursing students using latex gloves and her eyes swelled shut. Then she was at the dentist's office getting her teeth examined and again she had difficulty breathing and her eyes swelled. Blood was drawn the same day and it came back 1+ for latex allergy. (also see 1008795).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1008794 |
| MDR Report Key | 31711 |
| Date Received | 1996-04-02 |
| Date of Report | 1996-03-24 |
| Date of Event | 1995-01-01 |
| Date Added to Maude | 1996-04-08 |
| 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 | RUBBER DAM |
| Generic Name | RUBBER DAM |
| Product Code | EIE |
| Date Received | 1996-04-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 32851 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-04-02 |