MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2002-05-09 for TOOTH CONDITIONER GEL 646125 manufactured by L.d. Caulk.
[273699]
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
[321438]
The complaint could not be reproduced when return samples (where provided) and/or retain samples were evaluated. Therefore, co did not positively identify any failure mode or mechanism.
Patient Sequence No: 1, Text Type: D, B5
[327605]
Since the alleged defect could not be reproduced internally, co's conclusion is that the doctor did not properly attach the tip to the filled syringe. Also, the directions for use state "gel should flow freely with gentle pressure. Do not use excessive force. If not , remove syringe from pt field and check for obstruction. " failure to follow these instructions could lead to the complaints of tips coming off. The directions for use also state to "discard needles after use, as needles may clog if gel is allowed to dry inside. " clogged tips could create the need for excessive force, leading to potential failure.
Patient Sequence No: 1, Text Type: D, B5
[16145787]
A dentist alleges that the tip came off of a syringe and the material went onto a rubber dam in the patient's mouth. There was no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515379-2002-00027 |
| MDR Report Key | 393966 |
| Report Source | 00 |
| Date Received | 2002-05-09 |
| Date of Report | 2002-05-03 |
| Date of Event | 2002-04-10 |
| Date Mfgr Received | 2002-04-10 |
| Date Added to Maude | 2002-05-15 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | WILLIAM FREY, JR. |
| Manufacturer Street | 570 W. COLLEGE AVENUE P.O. BOX 872 |
| Manufacturer City | YORK PA 174050872 |
| Manufacturer Country | US |
| Manufacturer Postal | 174050872 |
| 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 |
| Generic Name | DENTAL RESTORATIVE MATERIAL |
| Product Code | EBC |
| Date Received | 2002-05-09 |
| Model Number | NA |
| Catalog Number | 646125 |
| Lot Number | 010109 |
| ID Number | * |
| 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 | 382977 |
| Manufacturer | L.D. CAULK |
| Manufacturer Address | 38 WEST CLARKE AVE. PO 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. Other | 2002-05-09 |