MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2002-10-22 for TOOTH CONDITIONER GEL SYRINGE 646125 manufactured by Dentsply Caulk.
[301625]
Tips were attached to the syringes and the syringes were then extruded. There is no formally documented method for this extrusion test; it is generally associated with appearance method gm-062-89.
Patient Sequence No: 1, Text Type: D, B5
[301912]
The returned syringe was difficult to extrude, but properly stored retained syringes extruded normally. Co's conclusion is thta the doctor did not properly store the filled syringe.
Patient Sequence No: 1, Text Type: D, B5
[17016931]
The returned syringe was difficult to extrude. The tip ios component #746129, and the filled syringe is component #946125. When applying the product, the doctor attaches an unused tip to the filled syringe and extrudes the material through the tip.
Patient Sequence No: 1, Text Type: D, B5
[21704596]
Clogged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515379-2002-00048 |
| MDR Report Key | 424586 |
| Report Source | 08 |
| Date Received | 2002-10-22 |
| Date of Report | 2002-09-24 |
| Date Mfgr Received | 2002-09-24 |
| Date Added to Maude | 2002-10-30 |
| 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 |
| Manufacturer Contact | DR. PATRICIA KIHN |
| Manufacturer Street | 570 W. COLLEGE AVENUE |
| Manufacturer City | YORK PA 17405 |
| Manufacturer Country | US |
| Manufacturer Postal | 17405 |
| Manufacturer Phone | 7178547511 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOOTH CONDITIONER GEL SYRINGE |
| Generic Name | DENTAL TOOTH CONDITIONER |
| Product Code | EBC |
| Date Received | 2002-10-22 |
| Model Number | NA |
| Catalog Number | 646125 |
| Lot Number | 020405 |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 413639 |
| Manufacturer | DENTSPLY CAULK |
| Manufacturer Address | 38 WEST MILFORD AVENUE 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. Other | 2002-10-22 |