MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-04-04 for ESPE PROMPT L-POP (DENTAL) * manufactured by 3-m.
[20925464]
The dental hygienist was preparing #18 tooth (lower right 2nd molar) to place a sculant. A "3-m" espe prompt l-pop was used to etch the tooth. They noticed a burn on the mucosa of the right cheek opposite to #18. There was no pain at the time. Rinsed and informed the pt and their family member. Followed up with a phone call to check on pt. No problem reported. The burn was a white lesion about 4 mm x 20 mm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1024596 |
| MDR Report Key | 387074 |
| Date Received | 2002-04-04 |
| Date of Report | 2002-03-25 |
| Date of Event | 2002-03-14 |
| Date Added to Maude | 2002-04-10 |
| 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 |
| Reporter Occupation | DENTIST |
| 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 | ESPE PROMPT L-POP (DENTAL) |
| Generic Name | ETCH/ADHESIVE FOR COMPOSIT FILLING |
| Product Code | DYH |
| Date Received | 2002-04-04 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 107536 |
| ID Number | * |
| Device Expiration Date | 2002-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 376101 |
| Manufacturer | 3-M |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-04-04 |