MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-03-14 for 450 SAL EJECTOR 3283 8881450004 manufactured by Covidien.
[21355888]
Submit date: (b)(4) 2012. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[21411918]
It was reported to covidien on (b)(6) 2012 that a customer had an issue with a saliva ejector. The customer reports that a pt was having an egd and being suctioned by one of our anesthesiologists and the blue part on the tip came off the tube and lodged into the pt's mouth. The customer reports that they were able to pull it out with forceps. The customer reports the pt status is fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2012-00020 |
| MDR Report Key | 2512349 |
| Report Source | 05,06 |
| Date Received | 2012-03-14 |
| Date of Report | 2012-03-09 |
| Report Date | 2012-03-09 |
| Date Reported to Mfgr | 2012-03-09 |
| Date Mfgr Received | 2012-03-09 |
| Date Added to Maude | 2012-08-29 |
| 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 | 0 |
| Manufacturer Contact | JANICE NEVIUS |
| Manufacturer Street | 15 HAMPSHIRE ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616283 |
| 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 | 2012-03-14 |
| 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 | CALLE 9 SUR NO. 125 CUI... TIJUANA 92173 MX 92173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-14 |