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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-12-10 for * manufactured by *.

Event Text Entries

[19779289] Mislabeled kleinhauer-betke stain (fetal hemoglobin stain kit). Lots involved 92549 and 92558. Lot 92549 has all bottles in lot are labeled as fixing solution when actually half the bottles are buffer solution. Lot 92558 has all bottles labeled as buffer solution when in fact, half the bottles are fixing solution.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4003423
• MDR Report Key: 435627
• Date Received: 2002-12-10
• Date of Report: 2002-12-10
• Date Added to Maude: 2003-01-06
• 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: 0
• 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: *
• Generic Name: *
• Product Code: GHQ
• Date Received: 2002-12-10
• Model Number: *
• Catalog Number: *
• Lot Number: 92549
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 424543
• Manufacturer: *
• Manufacturer Address: * * *

Device Sequence Number: 2

• Brand Name: *
• Generic Name: *
• Product Code: GHQ
• Date Received: 2002-12-10
• Model Number: *
• Catalog Number: *
• Lot Number: 92558
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 2
• Device Event Key: 424544
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2002-12-10