MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-11-29 for SICKLEDEX 773500 manufactured by Ortho-clinical Diagnostics, Inc..
[407333]
Customer reported that a negative reaction was observed with a hemoglobin s patient. No death or serious injury was associated with the incident.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2250051-2005-50561 |
MDR Report Key | 650084 |
Date Received | 2005-11-29 |
Date of Report | 2005-11-28 |
Date of Event | 2005-10-31 |
Date Added to Maude | 2005-12-08 |
Event Key | 0 |
Report Source Code | Distributor report |
Manufacturer Link | N |
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 | 3 |
Event Location | 3 |
Single Use | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | SICKLEDEX |
Generic Name | NA |
Product Code | JCM |
Date Received | 2005-11-29 |
Model Number | NA |
Catalog Number | 773500 |
Lot Number | 5172 |
ID Number | NA |
Device Expiration Date | 2006-06-27 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | * |
Implant Flag | N |
Date Removed | * |
Device Sequence No | 1 |
Device Event Key | 639561 |
Manufacturer | ORTHO-CLINICAL DIAGNOSTICS, INC. |
Manufacturer Address | 1001 US HWY 202 RARITAN NJ 08869 US |
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 | 1. Other | 2005-11-29 |