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 |