MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-11-26 for COMPULE SYRINGE (COMPULES TIPS GUN) 635105 manufactured by Dentsply Caulk.
[278319]
Dr alleged that while using a compule tip applicator gun, the tip (which the compule snaps into) fractured with a loud bang when pressure was applied to the handle. A fragment of plastic was propelled across the room. No one was injured. A second gun also fractured in use where the nozzle joins the body of the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515379-2002-00055 |
| MDR Report Key | 430673 |
| Report Source | 05 |
| Date Received | 2002-11-26 |
| Date of Report | 2002-10-29 |
| Date Mfgr Received | 2002-10-29 |
| Date Added to Maude | 2002-12-04 |
| 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 | DR. PATRICIA KIHN |
| Manufacturer Street | 570 W. COLLEGE AVE. |
| Manufacturer City | YORK PA 17405 |
| Manufacturer Country | US |
| Manufacturer Postal | 17405 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPULE SYRINGE (COMPULES TIPS GUN) |
| Generic Name | RESTORATIVE DISPENSING SYRINGE |
| Product Code | EID |
| Date Received | 2002-11-26 |
| Model Number | NA |
| Catalog Number | 635105 |
| 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 | 419654 |
| Manufacturer | DENTSPLY CAULK |
| Manufacturer Address | 38 WEST CLARKE AVE. MILFORD DE 19963 US |
| Baseline Brand Name | COMPULES TIPS GUN |
| Baseline Generic Name | RESTORATIVE MATERIAL COMPULE SYRINGE |
| Baseline Model No | NA |
| Baseline Catalog No | 635105 |
| Baseline ID | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-11-26 |