MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-01-29 for ACID ETCH TOOTH CONDITIONER GEL 646100 manufactured by Ld Caulk/dentsply.
[17482451]
The gel is contained in syringe system with a replaceable sterile tip. As the dentist was inserting the conditioner, the tip separated and fell into the pt's mouth. Pt went to the er and required a bronchoscopy to retrieve the tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1008216 |
| MDR Report Key | 29573 |
| Date Received | 1996-01-29 |
| Date of Event | 1995-11-10 |
| Date Added to Maude | 1996-02-05 |
| 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 | ACID ETCH TOOTH CONDITIONER GEL |
| Generic Name | TOOTH CONDITIONER GEL |
| Product Code | EBC |
| Date Received | 1996-01-29 |
| Model Number | 646100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 30633 |
| Manufacturer | LD CAULK/DENTSPLY |
| Manufacturer Address | LAKEVIEW CLARKE AVE MILFERD DE 199630359 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-01-29 |