MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-08-23 for 450 SAL EJECTOR 3283 8881450004 manufactured by Tyco/kendall Healthcare.
[463763]
A customer had a problem with an ejector. The customer states that the distal blue tip came off of the tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2005-00018 |
| MDR Report Key | 701987 |
| Report Source | 06 |
| Date Received | 2005-08-23 |
| Date of Report | 2005-08-16 |
| Date of Event | 2005-01-01 |
| Date Reported to Mfgr | 2005-08-16 |
| Date Mfgr Received | 2005-08-16 |
| Date Added to Maude | 2006-04-24 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| 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/KENDALL HEALTHCARE |
| 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 EJECTOR |
| Product Code | DYN |
| Date Received | 2005-08-23 |
| Model Number | 8881450004 |
| Catalog Number | 8881450004 |
| Lot Number | 506506864 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 691096 |
| Manufacturer | TYCO/KENDALL HEALTHCARE |
| Manufacturer Address | 9255 CUSTOMHOUSE PLAZA SAN DIEGO CA 92173 US |
| Baseline Brand Name | MONOJET 450 SAL EJECTOR 3283 |
| Baseline Generic Name | DENTAL PRODUCT |
| Baseline Model No | NA |
| Baseline Catalog No | 8881450004 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-08-23 |