MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-08-03 for 450 SAL EJECTOR 3283 8881450004 manufactured by Tyco/kendall Healthcare.
[693663]
It was reported to tyco/kendall healthcare that a customer had a problem with the sal ejector. The customer stated: the tip part was detached and lost in use. The pt was unconscious and transported to the emergency room, therefore the pt was not able to spit out any foreign material in his mouth. To find the tip fell off, the customer took an x-ray, but it could not be found. Two days later, during the oral care on the pt, the tip was found. No harm on the pt caused by this incident.
Patient Sequence No: 1, Text Type: D, B5
[7905046]
An investigation is currently underway; upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2007-00038 |
| MDR Report Key | 889024 |
| Report Source | 07 |
| Date Received | 2007-08-03 |
| Date of Report | 2007-07-18 |
| Date of Event | 2007-06-29 |
| Date Reported to Mfgr | 2007-07-18 |
| Date Mfgr Received | 2007-07-18 |
| Date Added to Maude | 2007-08-30 |
| 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, STE 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 | SAL EJECTOR |
| Product Code | DYN |
| Date Received | 2007-08-03 |
| Model Number | 8881450004 |
| Catalog Number | 8881450004 |
| Lot Number | 513506064 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 868142 |
| Manufacturer | TYCO/KENDALL HEALTHCARE |
| Manufacturer Address | 9255 CUSTOMHOUSE PLAZA SUITE A SAN DIEGO CA 92173 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-03 |