ELEXOMA MEDIC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-05 for ELEXOMA MEDIC manufactured by .

Event Text Entries

[5729138] Good morning, i received the elexoma medic device from (b)(6) and started on wednesday evening a first ces session (25min at 200uamp). Everything worked as mentioned on the manual with the bip when i started the device and when i reached 200uamp. I also put some water on the ear-clips just before to use them. I didn't feel anything special during the session. However, i woke up in the middle of the night (about 3-4h after this session) with a very strange feeling in my right ear (like if something was pulsing). Now, i hear less from this ear and have the same sensation as after a flight when ears are blocked/clogged. I went to the medical doctor and it seems that my internal ear is damaged. I started to take cortisone. In additional to this problem i wake up every night around 1 am with very big fear. I never had this before and cannot sleep anymore. In conclusion, i used the elexoma device for anxiety and after one session i have problem with my ear, panic attack during the night and don't sleep anymore at night. It is the opposite effect regarding what is described on your internet homepage. Please could you give me your feed-back on these issues and some advice to help me. It's a nightmare. I have never been feeling so bad. Thank you in advance. (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5042001
MDR Report Key4672583
Date Received2015-04-05
Date of Report2015-04-05
Date of Event2015-04-01
Date Added to Maude2015-04-10
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameELEXOMA MEDIC
Generic NameSTIMULATOR
Product CodeJXK
Date Received2015-04-05
OperatorLAY USER/PATIENT
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2015-04-05

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