MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-10-20 for DEFEND GENTLE - JECT SE-8000 manufactured by Mydent International.
[19951896]
Dentist called the sales rep advising that the tip of the saliva ejector had come loose. Dentist noticed this when placing in patient's mouth, so no harm was inflicted.
Patient Sequence No: 1, Text Type: D, B5
[20075397]
We plan to change glue to an alternative glue after we have tested possible replacements thoroughly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2435126-2005-00001 |
| MDR Report Key | 757079 |
| Report Source | 05 |
| Date Received | 2005-10-20 |
| Date of Report | 2005-10-19 |
| Date of Event | 2005-09-30 |
| Date Facility Aware | 2005-09-30 |
| Date Reported to Mfgr | 2005-09-30 |
| Date Mfgr Received | 2005-09-30 |
| Device Manufacturer Date | 2005-05-01 |
| Date Added to Maude | 2006-09-06 |
| 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 | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 80 SUFFOLK COURT |
| Manufacturer City | HAUPPAUGE NY 11788 |
| Manufacturer Country | US |
| Manufacturer Postal | 11788 |
| Manufacturer Phone | 6314343190 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEFEND GENTLE - JECT |
| Generic Name | SALIVA EJECTOR |
| Product Code | DYN |
| Date Received | 2005-10-20 |
| Model Number | SE-8000 |
| Catalog Number | SE-8000 |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 744982 |
| Manufacturer | MYDENT INTERNATIONAL |
| Manufacturer Address | 80 SUFFOLK COURT HAUPPAUGE NY 11788 US |
| Baseline Brand Name | DEFEND GENTLE - JECT |
| Baseline Generic Name | SALIVA EJECTOR |
| Baseline Model No | SE-8000 |
| Baseline Catalog No | SE-8000 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-10-20 |