BLUE LIGHT DERMATOLOGY TREATMENT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-17 for BLUE LIGHT DERMATOLOGY TREATMENT manufactured by .

Event Text Entries

[6432643] On (b)(6) 2013 i had the blue light treatment performed on my face/head to remove the pre-cancerous lesions from my face and, as advised, remained indoors for two days afterward. On saturday,(b)(4) i woke up with a slight amount of vision loss in my left eye. By (b)(4), when i visited my eye doctor, the condition had slightly worsened. After examination, the initial diagnosis was that i had probably suffered a slight stroke during my sleeping hours on the previous friday night that caused damage to my optic nerve resulting in some vision loss. The following days during that week the condition worsened further and when i returned to my eye doctor on monday, (b)(4) the vision had deteriorated to the point of complete blindness. After another examination he referred me to another eye doctor and i visited him the following day. This examination included removing some fluid from the eye and testing it against the various strains of the herpes virus. The result of the test indicated that the shingles virus strain was present in the fluid and that this had caused the blindness. The final theory was that, since i had the blue light treatment just prior to this incident, the shock of the procedure probably agitated the dormant shingles virus to attack my optic nerve and cause the resulting blindness. Finally, i must relate that during all of the above stated information i never experienced any pain in my eye. In the interim my thoughts have wavered to many avenues of theories and, since i hadn't experienced any of the pain that i've always heard is generally associated with a shingles outbreak, i keep wondering if the doctors' concluding theory is correct. Even though the shingles virus was discovered in the eye fluid it may have been there, in it's dormant state, for years and not suddenly agitated to hit the optic nerve. I keep returning to a possibility that the blue light treatment itself may have been the culprit. My investigation as to the side effects resulting from this procedure has not indicated anything other than the expected skin irritation and such. To that end, i am now in contact with your association to ascertain whether or not the blue light treatment, in itself, has caused any similar condition on anyone else that i am experiencing. Thank you for your hearing my thoughts and i will anticipate your reply as soon as possible.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5044592
MDR Report Key4935570
Date Received2015-07-17
Date of Report2015-07-17
Date of Event2013-09-05
Date Added to Maude2015-07-24
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 NameBLUE LIGHT DERMATOLOGY TREATMENT
Generic NameNONE
Product CodeMVF
Date Received2015-07-17
OperatorHEALTH PROFESSIONAL
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Deathisabilit 2015-07-17

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