PHOTODYNAMIC THERAPY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-24 for PHOTODYNAMIC THERAPY manufactured by Dusa Pharmaceuticals, Inc..

Event Text Entries

[81118671] I was recommended by faculty at (b)(6) to undergo "photodynamic therapy" for treatment of actinic keratosis on both hands and arm. I had the procedure at uic on (b)(6) both arms were treated with kerastick (levulan), left hand/arm exposed to blue light, right hand/arm exposed to red light. By evening, i experienced extreme itching, and by morning of (b)(6), i had extreme redness on both arms and hands. By afternoon of (b)(6), i developed severe blistering, swelling, pain and burning in both limbs. Uic prescribed triamcinolone and hydroxyzine, and i had to consult outside physicians for opinions. I spoke with dr. (b)(6) of (b)(6), who manufacture the drug kerastick, and he advised me that kerastick is only fda approved for use on scalp and face; the fda application for use of kerastick on limbs and extremities has only recently been made, so the uic physicians seem to have been conducting an unauthorized clinical experiment without my knowledge or permission. Dr. (b)(6) said that my reaction was unusual in its severity. Addendum by (b)(6) on (b)(6) 2017 2:37 pm (verified). Spoke with pt's husband, today and he stated that the pt was close by the phone, improving and blistering has been resolved. Blisters have dried out and the skin is becoming ready to peel. Husband has asked if any permanent skin pigment changes would follow this response. I have explained that we do not get any permanent pigment changes due to pdt and have strongly advice daily spf over 30, moisturization, avoidance of picking dry skin. Aggressive moisturization due to extensive reaction. Many cont tac and hydroxyzine as needed per itching symptoms. Husband and pt state that are very knowledgeable as far as wound care. Have offered to see the pt to clinic a f/u anytime but husband and pt state that are unable to come due to long distance which is understood. Strongly encouraged to rtc/call back with any add'l questions or concerns. Extensive education regarding the above entity. Husband - and pt expressed full understanding. All pt's questions were answered today.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5071186
MDR Report Key6739854
Date Received2017-07-24
Date of Report2017-06-16
Date of Event2017-06-06
Date Added to Maude2017-07-25
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePHOTODYNAMIC THERAPY
Generic NameSYSTEM, LASER, PHOTODYNAMIC THERAPY
Product CodeMVF
Date Received2017-07-24
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerDUSA PHARMACEUTICALS, INC.


Patients

Patient NumberTreatmentOutcomeDate
001. Deathisabilit 2017-07-24

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