MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-05-27 for COMFORT CONTROL SYRINGE 850155 manufactured by Dentsply Professional (midwest).
[19553441]
The doctor reported that about half the time the units are being used, the harpoon is not engaging the rubber stopper and therefore not aspirating properly. Two patients in the last year have had epenephrine attacks and were fine after a couple of minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419322-2003-00023 |
| MDR Report Key | 462553 |
| Report Source | 05 |
| Date Received | 2003-05-27 |
| Date of Report | 2000-04-28 |
| Date Mfgr Received | 2003-04-28 |
| Device Manufacturer Date | 2001-09-01 |
| Date Added to Maude | 2003-06-02 |
| 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 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| 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 | COMFORT CONTROL SYRINGE |
| Generic Name | CARTRIDGE SYRINGE, DENTAL |
| Product Code | EJI |
| Date Received | 2003-05-27 |
| Returned To Mfg | 2003-04-28 |
| Model Number | NA |
| Catalog Number | 850155 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 451502 |
| Manufacturer | DENTSPLY PROFESSIONAL (MIDWEST) |
| Manufacturer Address | 901 WEST OAKTON ST. DES PLAINES IL 60018 US |
| Baseline Brand Name | COMFORT CONTROL SYRINGE |
| Baseline Generic Name | CARTRIDGE SYRINGE, DENTAL |
| Baseline Model No | NA |
| Baseline Catalog No | 850155 |
| Baseline ID | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K002387 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-05-27 |