MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-02-06 for 450 SAL EJECTOR 3283 8881450004 manufactured by Covidien.
[19246398]
It was reported to covidien in early 2009 that a customer had an issue with a saliva ejector. The customer stated the blue tip part was detached in use and fell into the pt's mouth. The part was removed safely and no pt injury or medical intervention required.
Patient Sequence No: 1, Text Type: D, B5
[19328107]
An investigation is currently underway; upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2009-00007 |
| MDR Report Key | 1370564 |
| Report Source | 06 |
| Date Received | 2009-02-06 |
| Date of Report | 2009-01-06 |
| Date of Event | 2008-12-26 |
| Report Date | 2009-01-06 |
| Date Reported to Mfgr | 2009-01-06 |
| Date Mfgr Received | 2009-01-06 |
| Date Added to Maude | 2009-07-24 |
| 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 | ELAINE BISHOP |
| Manufacturer Street | 15 HAMPSHIRE ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524686 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 2660 SARNEN ST, STE 220 |
| Manufacturer City | SAN DIEGO CA 92154 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92154 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 450 SAL EJECTOR 3283 |
| Generic Name | SALIVA EJECTOR |
| Product Code | DYN |
| Date Received | 2009-02-06 |
| Model Number | 8881450004 |
| Catalog Number | 8881450004 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 2660 SARNEN ST, STE 220 SAN DIEGO CA 92154 US 92154 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-02-06 |