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.
[686142]
It was reported to tyco/kendall healthcare that a customer had a problem with a sal ejector. The customer stated: the tip part was detached.
Patient Sequence No: 1, Text Type: D, B5
[7809274]
An investigation is currently underway; upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2007-00037 |
| MDR Report Key | 889025 |
| Report Source | 07 |
| Date Received | 2007-08-03 |
| Date of Report | 2007-07-12 |
| Date of Event | 2007-07-10 |
| Date Reported to Mfgr | 2007-07-12 |
| Date Mfgr Received | 2007-07-12 |
| 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 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 | SAL EJECTOR |
| Product Code | DYN |
| Date Received | 2007-08-03 |
| Model Number | 8881450004 |
| Catalog Number | 8881450004 |
| Lot Number | 701504464 |
| 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 | 868148 |
| 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 |