MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-08-30 for 450 SAL EJECTOR 3283 8881450004 manufactured by Tyco/kendall Healthcare.
[682038]
It was reported to tyco/kendall healthcare that a customer had a problem with the dental sal ejector. The dealer reports that the tip of the saliva ejector fell off when it was being manipulated by the office staff. The ejector was grabbed by the blue tip, and by the shaft, and the blue tip broke off. The ejector was not in use on a patient when the tip fell off. "
Patient Sequence No: 1, Text Type: D, B5
[7864315]
An investigation is currently underway upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2007-00041 |
| MDR Report Key | 904255 |
| Report Source | 07 |
| Date Received | 2007-08-30 |
| Date of Report | 2007-08-22 |
| Date of Event | 2007-07-09 |
| Report Date | 2007-08-22 |
| Date Reported to Mfgr | 2007-08-22 |
| Date Mfgr Received | 2007-08-22 |
| Date Added to Maude | 2007-11-23 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | ADRIENNE MARCELLUS, RN |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618441 |
| Manufacturer G1 | TYCO HEALTHCARE/KENDALL |
| Manufacturer Street | 9255 CUSTOMHOUSE PLAZA SUITE A |
| Manufacturer City | SAN DIEGO CA 92173 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92173 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 450 SAL EJECTOR 3283 |
| Generic Name | DENTAL EJECTOR |
| Product Code | DYN |
| Date Received | 2007-08-30 |
| Model Number | 8881450004 |
| Catalog Number | 8881450004 |
| Lot Number | 630303864 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 921568 |
| Manufacturer | TYCO/KENDALL HEALTHCARE |
| Manufacturer Address | 9255 CUSTOMHOUSE PLAZA SAN DIEGO CA 92173 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-30 |