FDA Adverse Event
Summary report: N
LATEX EXAM GLOVE
MDR report key: 34231
·
Received July 18, 1996
Report
- Report Number
- MW1009506
- Date Received
- July 18, 1996
- Date of Event
- June 16, 1996
- Report Date
- July 8, 1996
- Manufacturer
- CAL-AMERICAN EXPORTS, INC.
- Product Code
- LYY
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MS, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
WITHIN 1 TO 3 DAYS PT AHD ULCERATIONS AND BURNING OF LIP AND TONGUE AFTER ROUTINE DENTAL PROPHYLAXIS. RESPONDED TO MEDICATED RINSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LATEX EXAM GLOVE | LATEX EXAM GLOVE | LYY | CAL-AMERICAN EXPORTS, INC. | 80905 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |