MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2004-02-06 for ALPHA IV REV. 2 40MM ACTIVE TRANSFER A1733 TDA-0040 manufactured by Novoste Corp..
[17488556]
The transfer device serial # on the calibration certificate did not match the serial # of the transfer device that was received at the site. The mistake was identified by the customer during the receiving qa procedures established for handling radioactive materials. The transfer device was not used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1062385-2004-00001 |
| MDR Report Key | 518762 |
| Report Source | 06 |
| Date Received | 2004-02-06 |
| Date of Report | 2004-01-27 |
| Date of Event | 2004-01-06 |
| Date Added to Maude | 2004-04-05 |
| 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 | 0 |
| Manufacturer Contact | ADAM LOWE, VP |
| Manufacturer Street | 3890 STEFE REYNOLDS BLVD. |
| Manufacturer City | NORCROSS GA 30093 |
| Manufacturer Country | US |
| Manufacturer Postal | 30093 |
| Manufacturer Phone | 7707170904 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALPHA IV REV. 2 40MM ACTIVE TRANSFER |
| Generic Name | TRANSFER DEVICE |
| Product Code | MOU |
| Date Received | 2004-02-06 |
| Returned To Mfg | 2004-01-05 |
| Model Number | A1733 |
| Catalog Number | TDA-0040 |
| Lot Number | NA |
| ID Number | 520290-042 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 507792 |
| Manufacturer | NOVOSTE CORP. |
| Manufacturer Address | 3890 STEVE REYNOLDS BLVD. NORCROSS GA 30093 US |
| Baseline Brand Name | ALPHA IV REV. 2, 40MM ACTIVE TRANSFER DEVICE |
| Baseline Generic Name | TRANSFER DEVICE |
| Baseline Model No | A1733 |
| Baseline Catalog No | WLC-0001-042/TDA-0040-042 |
| Baseline ID | NA |
| Baseline Device Family | ALPHA IV REV 2 TRANSFER DEVICE |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 6 |
| Baseline PMA Flag | Y |
| Premarket Approval | P0000 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-02-06 |