MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1999-10-20 for I.A. EXTENSION BOARD manufactured by Steris Corp..
Report Number | 1043572-1999-00005 |
MDR Report Key | 246692 |
Report Source | 06 |
Date Received | 1999-10-20 |
Date of Event | 1999-09-16 |
Date Mfgr Received | 1999-09-21 |
Date Added to Maude | 1999-11-01 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 0 |
Product Problem Flag | 0 |
Reprocessed and Reused Flag | 0 |
Health Professional | 0 |
Initial Report to FDA | 0 |
Report to FDA | 0 |
Event Location | 0 |
Manufacturer Contact | ROBERT MCCALL |
Manufacturer Street | 2720 GUNTER PARK DR E |
Manufacturer City | MONTGOMERY LA 36109 |
Manufacturer Country | US |
Manufacturer Postal | 36109 |
Manufacturer Phone | 3342133150 |
Manufacturer G1 | * |
Manufacturer Street | * |
Manufacturer City | * |
Manufacturer Country | * |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | I.A. EXTENSION BOARD |
Generic Name | SURGICAL TABLE ACCESSORY |
Product Code | FSE |
Date Received | 1999-10-20 |
Returned To Mfg | 1999-10-05 |
Model Number | NA |
Catalog Number | NA |
Lot Number | NA |
ID Number | NA |
Device Availability | Y |
Device Eval'ed by Mfgr | Y |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 238975 |
Manufacturer | STERIS CORP. |
Manufacturer Address | 2720 GUNTER PARK DRIVE E. MONTGOMERY AL 36109 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1999-10-20 |