TRANSQ SM
Received Jul 2, 2009 · Event occurred May 4, 2009
Report 1721293-2009-00007 · MDR key 1410614
Product problems
- Insufficient Device Problem Information
Patient
75 YR
- Superficial (First Degree) Burn
Narrative
Description of Event or Problem
PT RECEIVED BURNS DURING IONTOPHORESIS. ELECTRODE PLACEMENT ON THE VEIL ZONE, RIGHT AND LEFT WRISTS FOR TENOSUNOVITIS. BURNS CLASSIFIED AS 1ST DEGREE. BURN OCCURRED ON 5TH TREATMENT. MEDICATION DELIVERED THROUGH TREATMENT WAS KETOPROFEN, DOSAGE 2.0CC. PATIENT IS REPORTED AS HAVING NO PREEXISTING CONDITIONS. WAVE FORM USED FOR TREATMENT WAS CONSTANT CURRENT. INTENSITY WAS NOT DISCLOSED. TREATMENT WAS INTERRUPTED BUT PROGRESS TOWARD RECOVERY WAS NOT IMPEDED. PATIENT REQUIRED LOCAL PHARMACOLOGIC MEDICAL INTERVENTION.
Additional Manufacturer Narrative
DEVICE NOT YET RECEIVED BY MANUFACTURER FOR INSPECTION AND EVALUATION. ANY ADDITIONAL INFORMATION THAT MAY BE OBTAINED WILL BE SENT IN A FOLLOW-UP WHEN AVAILABLE.