INTERCEPT ORAL *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-07-31 for INTERCEPT ORAL * manufactured by Orasure.

Event Text Entries

[352630] Use of orasure oral intercept drug test resulted in gluten allergic response. No allergy warning provided by mfr.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1032881
• MDR Report Key: 549930
• Date Received: 2004-07-31
• Date of Report: 2004-07-31
• Date of Event: 2004-07-31
• Date Added to Maude: 2004-10-21
• 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
• Reporter Occupation: PHARMACIST
• 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 Details

• Brand Name: INTERCEPT ORAL
• Generic Name: DRUG SCREEN
• Product Code: MVO
• Date Received: 2004-07-31
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 539448
• Manufacturer: ORASURE
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2004-07-31