ANTI-DESMIN PRIMARY ANTIBODY 760-2513

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 2003-12-22 for ANTI-DESMIN PRIMARY ANTIBODY 760-2513 manufactured by Ventana Medical Systems, Inc..

MAUDE Entry Details

• Report Number: 2028492-2003-00005
• MDR Report Key: 505120
• Report Source: 05
• Date Received: 2003-12-22
• Date of Report: 2003-12-19
• Date of Event: 2003-10-01
• Date Mfgr Received: 2003-12-09
• Date Added to Maude: 2004-01-09
• 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: 3
• Event Location: 0
• Manufacturer Contact: SAM RUA, DIR
• Manufacturer Street: 1910 INNOVATION PARK DR
• Manufacturer City: TUCSON AZ 85737
• Manufacturer Country: US
• Manufacturer Postal: 85737
• Manufacturer Phone: 5202293911
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ANTI-DESMIN PRIMARY ANTIBODY
• Generic Name: IHC PRIMARY ANTIBODY
• Product Code: MVU
• Date Received: 2003-12-22
• Model Number: NA
• Catalog Number: 760-2513
• Lot Number: 21440B
• ID Number: *
• Device Expiration Date: 2004-06-04
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 493989
• Manufacturer: VENTANA MEDICAL SYSTEMS, INC.
• Manufacturer Address: 1910 INNOVATION PARK DR. TUCSON AZ 85737 US
• Baseline Brand Name: ANTI-DESMIN PRIMARY ANTIBODY
• Baseline Generic Name: IHC PRIMARY ANTIBODY
• Baseline Model No: NA
• Baseline Catalog No: 760-2513
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-12-22