MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-10-04 for 450 SAL EJECTOR 3283 * 8881450004 manufactured by Tyco Healthcare / Kendall.
[698135]
It was reported to tyco healthcare / kendall that a customer experienced a problem with the saliva enjectors. The customer reports that the blue tip detached from the ejector in the airway of a patient.
Patient Sequence No: 1, Text Type: D, B5
[7858946]
An investigation is currently underway. Upon completion of the investigation, results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2004-00005 |
| MDR Report Key | 916506 |
| Report Source | 07 |
| Date Received | 2004-10-04 |
| Date of Report | 2004-09-29 |
| Report Date | 2004-09-29 |
| Date Reported to Mfgr | 2004-09-29 |
| Date Mfgr Received | 2004-09-29 |
| Date Added to Maude | 2007-09-21 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHARON GREEN |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616620 |
| Manufacturer G1 | KENMEX |
| 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 |
| Product Code | DYN |
| Date Received | 2004-10-04 |
| Returned To Mfg | 2004-10-04 |
| Model Number | * |
| Catalog Number | 8881450004 |
| Lot Number | 412606364 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 889413 |
| Manufacturer | TYCO HEALTHCARE / KENDALL |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-10-04 |