The manufacturer became aware of an allegation that a user after wearing a wisp mask with magnetic connections, the user reportedly had a seizure.The user has a history of seizures and has an implanted shunt and vns for his seizures.The following day it was also reported the user suffered 7 additional seizures.The mother of the user reported she is not sure if the seizures were related to the magnets in the mask or not.There was no report of medical intervention.Several attempts were made to contact the user's mother for the return of the mask for investigation.No product was returned for investigation.The wisp instructions for use includes the following warnings: the headgear clips contain magnets.Contact your healthcare professional before you use this mask.Some medical devices may be affected by magnetic fields.The magnetic clips in this mask should be kept at least 2 in.(50 mm) away from any active medical device with special attention to implanted devices such as pacemakers, defibrillators and cochlear implants.Do not use in or near magnetic resonance imaging (mri) equipment.Keep unassembled magnetic headgear clips out of reach of children.In case of accidental swallowing, seek medical assistance immediately.This report will be filed as an initial-final report.We will continue to monitor these complaints regarding magnets.If any additional information is received, a follow up report will be filed.
|