UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-01-16 for UNKNOWN manufactured by Unknown.

Event Text Entries

[1311122] Pt arrived at (b) (6) airport and entered security screening prior to entering the secure concourse. Pt was selected for enhanced screening during which he passed through a radiological body scanning system. Initially, the report from the operator, as heard on the two-way walkie talkie, was that pt appeared to be a suitcase. After some procedure and an additional scan, the operator informed the tsa officer manning the device that the pt had something in the area of his waistband. After being physically searched and having spent several minutes in the scanning device, pt was released and allowed to continue on to his flight. Within 90 minutes of the scan, pt had rapid onset and severe supra clavicular lymphadenopathy and edema with swelling extended from just below the jaw line to a peak above the clavicular lymph basin on pt's left side only. Total edema size would best be likened to that of a large orange. The edema resolved over the following week, but nodal size remained constant. Upon inspection by the family physician, the pt was referred out for an excision biopsy. Fine needle aspiration prior to the surgical biopsy was negative. Biopsy revealed a-typical cells indicating nodular sclerosing hodgkin's lymphoma.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5014396
MDR Report Key1584188
Date Received2010-01-16
Date of Report2010-01-16
Date of Event2008-11-01
Date Added to Maude2010-01-25
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN
Generic NameFULL BODY SCANNING SYSTEM LANE 3
Product CodeJAO
Date Received2010-01-16
Lot NumberUNK
ID NumberUNK
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerUNKNOWN
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2010-01-16

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