MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2007-02-20 for WRIGHT GIEMSA STAIN VWG manufactured by Volu-sol, Inc..
[17959187]
Received this report without the second page. Per fda directive on (b)(6) 2011, this report will be processed as is.
Patient Sequence No: 1, Text Type: N, H10
[18043361]
The stabilizer, glycerol was added to enhance the boldness of color and increase clarity. This enhanced product caused water artifact on rbc's.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002805583-2007-00001 |
| MDR Report Key | 2195570 |
| Report Source | 99 |
| Date Received | 2007-02-20 |
| Date of Report | 2007-02-15 |
| Date of Event | 2007-01-16 |
| Date Added to Maude | 2011-08-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WRIGHT GIEMSA STAIN |
| Generic Name | WRIGHT GIEMSA STAIN |
| Product Code | IAF |
| Date Received | 2007-02-20 |
| Catalog Number | VWG |
| Lot Number | 615 |
| Device Expiration Date | 2008-01-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VOLU-SOL, INC. |
| Manufacturer Address | SALT LAKE CITY UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-02-20 |