ANTIBODY DESMIN FOR VENTANA NEXES INSTRUMENT NEXES - 4 MODULES 760-2513

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-12-10 for ANTIBODY DESMIN FOR VENTANA NEXES INSTRUMENT NEXES - 4 MODULES 760-2513 manufactured by Ventana Medical Systems, Inc..

Event Text Entries

[20991277] During registration of reagent, computer stated new unopened antibody had expired 08/2003, when the container reads 04-june-04. The company is shipping a new button to register product and a new bar code label.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1030492
• MDR Report Key: 502642
• Date Received: 2003-12-10
• Date of Report: 2003-10-01
• Date of Event: 2003-10-01
• Date Added to Maude: 2003-12-29
• Event Key: 0
• Report Source Code: Voluntary 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: ANTIBODY DESMIN FOR VENTANA NEXES INSTRUMENT
• Generic Name: *
• Product Code: MVU
• Date Received: 2003-12-10
• Model Number: NEXES - 4 MODULES
• Catalog Number: 760-2513
• Lot Number: 21440B
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 491412
• Manufacturer: VENTANA MEDICAL SYSTEMS, INC.
• Manufacturer Address: 1910 INNOVATION PARK DRIVE TUSCAN AZ 85737 US

Device Sequence Number: 2

• Brand Name: ANTIBODY DESMIN FOR VENTANA NEXES INSTRUMENT
• Generic Name: *
• Product Code: MVU
• Date Received: 2003-12-10
• Model Number: NEXES - 4 MODULES
• Catalog Number: 760-2513
• Lot Number: 21440B
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 491414
• Manufacturer: VENTANA MEDICAL SYSTEMS, INC.
• Manufacturer Address: 1910 INNOVATION PARK DRIVE TUSCAN AZ 85737 US

Device Sequence Number: 3

• Brand Name: ANTIBODY DESMIN FOR VENTANA NEXES INSTRUMENT
• Generic Name: *
• Product Code: MVU
• Date Received: 2003-12-10
• Model Number: NEXES - 4 MODULES
• Catalog Number: 760-2513
• Lot Number: 21440B
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 491417
• Manufacturer: VENTANA MEDICAL SYSTEMS, INC.
• Manufacturer Address: 1910 INNOVATION PARK DRIVE TUSCAN AZ 85737 US

Device Sequence Number: 4

• Brand Name: ANTIBODY DESMIN FOR VENTANA NEXES INSTRUMENT
• Generic Name: *
• Product Code: MVU
• Date Received: 2003-12-10
• Model Number: NEXES - 4 MODULES
• Catalog Number: 760-2513
• Lot Number: 21440B
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 4
• Device Event Key: 491419
• Manufacturer: VENTANA MEDICAL SYSTEMS, INC.
• Manufacturer Address: 1910 INNOVATION PARK DRIVE TUSCAN AZ 85737 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-12-10