MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-08-17 for CAULK TOOTH CONDITIONER GEL 34% 646125 manufactured by Dentsply Caulk.
[15034000]
An ophthalmologist reported that a patient sustained a corneal burn after exposure to tooth conditioner gel; the reporter disconnected the call before providing any further information.
Patient Sequence No: 1, Text Type: D, B5
[15303873]
While it is unknown what, if any, intervention was required to treat the burn, it is likely that such an injury would require intervention to preclude permanent damage to a body structure and permanent impairment of a body function. There is not enough information available at this time to determine whether the product malfunctioned or not. The device was not returned for evaluation and the lot number is not known for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515379-2006-00369 |
| MDR Report Key | 751733 |
| Report Source | 05 |
| Date Received | 2006-08-17 |
| Date of Report | 2006-07-18 |
| Date of Event | 2006-07-18 |
| Date Mfgr Received | 2006-07-18 |
| Date Added to Maude | 2006-08-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR. PATRICIA KIHN |
| Manufacturer Street | 221 W. PHILA. ST STE 60 |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY CAULK |
| Manufacturer Street | 38 W. CLARKE AVE |
| Manufacturer City | MILFORD DE 19963 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19963 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAULK TOOTH CONDITIONER GEL 34% |
| Generic Name | EBC |
| Product Code | EBC |
| Date Received | 2006-08-17 |
| Model Number | NA |
| Catalog Number | 646125 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 739537 |
| Manufacturer | DENTSPLY CAULK |
| Manufacturer Address | * MILFORD DE * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-08-17 |