MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1999-10-14 for CONTOUR EMBOLIZATION PARTICLES 760082 manufactured by Target Therapeutics/a Div Of Boston Scientific Corp..
[184833]
It was reported to target that during an experiment conducted by a marketing mgr of one of boston scientific divisions, it was found that the product had a wrong label; the particles in the vial were undersized. Since this was noted during an experiment in an outside research facility's lab, there was no pt involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000078-1999-00092 |
| MDR Report Key | 245232 |
| Report Source | 00 |
| Date Received | 1999-10-14 |
| Date of Report | 1999-10-14 |
| Date Mfgr Received | 1999-09-22 |
| Device Manufacturer Date | 1999-02-01 |
| Date Added to Maude | 1999-10-20 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | CARMEN ORELLANA |
| Manufacturer Street | 47900 BAYSIDE PKWY |
| Manufacturer City | FREMONT CA 945386515 |
| Manufacturer Country | US |
| Manufacturer Postal | 945386515 |
| Manufacturer Phone | 8006622415 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTOUR EMBOLIZATION PARTICLES |
| Generic Name | EMBOLIZATION PARTICLES |
| Product Code | MZQ |
| Date Received | 1999-10-14 |
| Returned To Mfg | 1999-09-22 |
| Model Number | NA |
| Catalog Number | 760082 |
| Lot Number | A74000 |
| ID Number | NA |
| Device Expiration Date | 2002-01-01 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 237590 |
| Manufacturer | TARGET THERAPEUTICS/A DIV OF BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | 47900 BAYSIDE PKWY FREMONT CA 945386515 US |
| Baseline Brand Name | CONTOUR EMBOLIZATION PARTICLES |
| Baseline Generic Name | PVA |
| Baseline Model No | NA |
| Baseline Catalog No | 760082 |
| Baseline ID | NA |
| Baseline Device Family | CONTOUR |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K914866 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-10-14 |