MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07,08 report with the FDA on 2011-11-14 for 450 SAL EJECTOR 3283 8881450004 manufactured by Covidien.
[19651108]
Submit date: (b)(4) 2011. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[19674030]
It was reported to covidien on (b)(6) 2011 that a customer had an issue with a saliva ejector. The customer reports that the blue tip detached in the pt's mouth during a procedure. The tip was successfully removed with no impact or harm to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2011-00018 |
| MDR Report Key | 2369421 |
| Report Source | 05,06,07,08 |
| Date Received | 2011-11-14 |
| Date of Report | 2011-10-27 |
| Date of Event | 2011-10-26 |
| Date Facility Aware | 2011-10-26 |
| Report Date | 2011-10-27 |
| Date Reported to Mfgr | 2011-10-27 |
| Date Mfgr Received | 2011-10-27 |
| Date Added to Maude | 2012-07-13 |
| 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 | NICHOLAS KOTYK |
| Manufacturer Street | 15 HAMPSHIRE ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616620 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL |
| Manufacturer City | TIJUANA 92173 |
| Manufacturer Country | MX |
| 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 | SALIVA EJECTOR |
| Product Code | DYN |
| Date Received | 2011-11-14 |
| Model Number | 8881450004 |
| Catalog Number | 8881450004 |
| Lot Number | 115004164 |
| 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 | CALLE 9 SUR NO. 125 TIJUANA 92173 MX 92173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-14 |