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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 2007-01-12 for * manufactured by *.

Event Text Entries

[21257750] A woman enrolled in a research study to assess the effects of gastric bypass on cardiac fat metabolism with pet. The study was performed with radioactive drugs, "generally recognized as safe and effective" in accordance with 21 cfr 361. 1. She was undergoing a repeat pet study following surgery. Upon receiving an injection of c-11 palmitate, the subject developed intense coughing with associated dyspnea. She was immediately removed from the pet scanner and her symptoms resolved within 2-3 mins. Her physical examination by both an md and a nurse were unremarkable. No other treatment was necessary. She remained asymptomatic at 24 and 48 hrs after the event. She was removed from further participation in the study. Of note, her baseline (preoperative) pet study with c-11 palmitate was accomplished without incident. Of note, the subject reported tasting and smelling ether after the injection. It was judged that her reaction most likely reflected an idiosyncratic sensitivity to the small amount of the ether in the ejectate. Similar problems have not been in many other administrations of this radioactive drug to hundreds of human subjects over the last 25 yrs.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1041614
• MDR Report Key: 805077
• Date Received: 2007-01-12
• Date of Report: 2007-01-03
• Date of Event: 2006-11-29
• Date Added to Maude: 2007-01-17
• 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: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NA
• Generic Name: C-11 PALMITATE
• Product Code: KTA
• Date Received: 2007-01-12
• Model Number: *
• Catalog Number: *
• Lot Number: P1-112906
• ID Number: *
• Device Expiration Date: 2006-11-29
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 792574
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2007-01-12