WRIGHT GIEMSA STAIN VWG

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-02-20 for WRIGHT GIEMSA STAIN VWG manufactured by Volu-sol, Inc..

Event Text Entries

[2140964] 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

[9139629] This was the final lot that contained the additive glycerol and future lots will not contain the additive.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 3002805583-2007-00002
• MDR Report Key: 2172001
• Report Source: 05
• Date Received: 2007-02-20
• Date of Report: 2007-02-15
• Date of Event: 2007-01-16
• Date Mfgr Received: 2007-01-16
• Device Manufacturer Date: 2006-11-01
• Date Added to Maude: 2011-07-28
• 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
• Manufacturer Street: 5095W 2100S
• Manufacturer City: SALT LAKE CITY UT 84120
• Manufacturer Country: US
• Manufacturer Postal: 84120
• Manufacturer Phone: 8668212495
• Single Use: 3
• Remedial Action: RC
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: WRIGHT GIEMSA STAIN
• Generic Name: WRIGHT GIEMSA STAIN
• Product Code: GJH
• Date Received: 2007-02-20
• Catalog Number: VWG
• Lot Number: 616
• Device Expiration Date: 2008-01-28
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: VOLU-SOL, INC.
• Manufacturer Address: SALT LAKE CITY UT US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2007-02-20