PERSANTINE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-09-24 for PERSANTINE * manufactured by *.

Event Text Entries

[331492] Complainant went to hospital to undergo a persantine thallium stress test. They stated that they are allergic to heparin, codeine, and penicillin. The complainant was asked the name of the performing physician but they did not know it. They did stated that it was performed by the nuclear medicine dept. When the test was performed, pt notified them that they had an itching and burning sensation in their chest. They told pt the sensation was normal and would go away by itself. Pt was prescribed cortisone to alleviate the symptoms. The sensations still persist to this day in fluctuating severities. Pt stated that they also noticed hair loss. Pt stated that they have been prescribed rogaine by a dermatologist and the hair recovery has been slow but it is growing back. The complainant stated that they beleive that their allergies were ignored by the physicians despite the fact that they were listed on their id bracelet.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4003579
• MDR Report Key: 490440
• Date Received: 2003-09-24
• Date of Report: 2003-09-05
• Date of Event: 2002-10-10
• Date Added to Maude: 2003-10-23
• 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
• Reporter Occupation: PATIENT
• 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: PERSANTINE
• Generic Name: THALLIUM STRESS TEST
• Product Code: JWM
• Date Received: 2003-09-24
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 479174
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-09-24