MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-07-06 for TOOTH CONDITIONER GEL 646125 manufactured by L.d. Caulk.
[142220]
The tip of the syringe cracked and material squirted onto the pt's face and the back of her neck, getting into the pt's eye. The pt was treated by an ophthalmologist. At this point, there is no swelling or any other indication of damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515379-1999-00007 |
| MDR Report Key | 230775 |
| Report Source | 05 |
| Date Received | 1999-07-06 |
| Date of Report | 1999-07-06 |
| Date of Event | 1999-06-24 |
| Date Mfgr Received | 1999-06-24 |
| Date Added to Maude | 1999-07-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOOTH CONDITIONER GEL |
| Generic Name | TOOTH CONDITIONER GEL |
| Product Code | EBC |
| Date Received | 1999-07-06 |
| 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 | A |
| Device Sequence No | 1 |
| Device Event Key | 223752 |
| Manufacturer | L.D. CAULK |
| Manufacturer Address | 38 WEST CLARKE AVE. P.O. BOX 359 MILFORD DE 199630359 US |
| Baseline Brand Name | CAULK TOOTH CONDITION GEL 34% |
| Baseline Generic Name | PIT AND FISSURE SEALANT AND CONDITIONER |
| Baseline Model No | NA |
| Baseline Catalog No | 646125 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K942031 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-07-06 |