MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,02,03 report with the FDA on 2007-04-20 for FINAL TESTING PRODUCTION. WILL BE DELETED. manufactured by Boston Scientific Corp..
| Report Number | 6000111-2000-00001 |
| MDR Report Key | 838996 |
| Report Source | 01,02,03 |
| Date Received | 2007-04-20 |
| Date of Report | 2007-04-07 |
| Date of Event | 2007-04-06 |
| Date Facility Aware | 2007-04-11 |
| Report Date | 2007-04-14 |
| Date Reported to FDA | 2007-04-11 |
| Date Reported to Mfgr | 2007-04-13 |
| Date Mfgr Received | 2007-04-11 |
| Device Manufacturer Date | 2007-04-12 |
| Date Added to Maude | 2007-04-20 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MR. TEST TEST |
| Manufacturer Street | ONE BOSTON SCIENTIFIC PLACE TEST |
| Manufacturer City | NATICK MA 017602343 |
| Manufacturer Country | US |
| Manufacturer Postal | 0176023432 |
| Manufacturer Phone | 1121231232 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORP. |
| Manufacturer Street | ONE BOSTON SCIENTIFIC PLACE TEST |
| Manufacturer City | NATICK MA 01760234 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01760 2342 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FINAL TESTING PRODUCTION. WILL BE DELETED. |
| Generic Name | FINAL TESTING PRODUCTION. WILL BE DELETED. |
| Product Code | MCZ |
| Date Received | 2007-04-20 |
| Model Number | TEST |
| Catalog Number | TEST |
| Lot Number | TEST |
| ID Number | TEST |
| Device Expiration Date | 2007-04-07 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DAY |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 826298 |
| Manufacturer | BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | ONE BOSTON SCIENTIFIC PLACE TEST NATICK MA 017602342 US 2342342222 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2007-04-20 |