MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-11-29 for manufactured by .
Report Number | 2250051-2005-00561 |
MDR Report Key | 650088 |
Report Source | 05,06 |
Date Received | 2005-11-29 |
Date of Event | 2005-10-31 |
Date Mfgr Received | 2005-10-31 |
Device Manufacturer Date | 2005-06-01 |
Date Added to Maude | 2005-12-08 |
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 | LAURA VELLUCCI, PH.D |
Manufacturer Street | 1001 US HWY 202 |
Manufacturer City | RARITAN NJ 08869 |
Manufacturer Country | US |
Manufacturer Postal | 08869 |
Manufacturer Phone | 9082188532 |
Manufacturer G1 | * |
Manufacturer Street | * |
Manufacturer City | * |
Manufacturer Country | * |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Product Code | JCM |
Date Received | 2005-11-29 |
Device Eval'ed by Mfgr | * |
Implant Flag | N |
Device Sequence No | 1 |
Device Event Key | 639561 |
Baseline Brand Name | SICKLEDEX |
Baseline Generic Name | NA |
Baseline Model No | NA |
Baseline Catalog No | 773500 |
Baseline ID | NA |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2005-11-29 |