MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2001-06-05 for manufactured by .
Report Number | 8044101-2001-00001 |
MDR Report Key | 336338 |
Report Source | 04 |
Date Received | 2001-06-05 |
Date of Event | 2001-05-09 |
Date Mfgr Received | 2001-05-09 |
Device Manufacturer Date | 2000-04-01 |
Date Added to Maude | 2001-06-11 |
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 | MARY LEEPER, PHD |
Manufacturer Street | 875 N MICHIGAN AVE #3660 |
Manufacturer City | CHICAGO IL 60611 |
Manufacturer Country | US |
Manufacturer Postal | 60611 |
Manufacturer Phone | 3122809917 |
Manufacturer G1 | * |
Manufacturer Street | * |
Manufacturer City | * |
Manufacturer Country | * |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Product Code | MBU |
Date Received | 2001-06-05 |
Device Eval'ed by Mfgr | N |
Implant Flag | N |
Date Removed | * |
Device Sequence No | 1 |
Device Event Key | 325642 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2001-06-05 |