*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-12-27 for * manufactured by Ortho-clinical Diagnostics, Inc..

Event Text Entries

[8054176] The hhp wand scanner on the oas server misread sample bar code labels on three different occasions. Failure investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2250051-2004-00536
• MDR Report Key: 810096
• Report Source: 05,06
• Date Received: 2004-12-27
• Date Mfgr Received: 2004-12-07
• Device Manufacturer Date: 1992-01-01
• Date Added to Maude: 2007-01-31
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: LAURA VELLUCCI, PH.D
• Manufacturer Street: 1001 US HWY 202
• Manufacturer City: RARITAN NJ 08869
• Manufacturer Country: US
• Manufacturer Postal: 08869
• Manufacturer Phone: 9082188532
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: *
• Product Code: LRH
• Date Received: 2004-12-27
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 797580
• Manufacturer: ORTHO-CLINICAL DIAGNOSTICS, INC.
• Manufacturer Address: ROUTE 202 RARITAN NJ 08869 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-12-27