TRANSQ SM
Received Jul 2, 2009 · Event occurred Feb 23, 2009
Report 1721293-2009-00008 · MDR key 1410612
Product problems
- Insufficient Device Problem Information
Patient
62 YR
- Full thickness (Third Degree) Burn
Narrative
Additional Manufacturer Narrative
ANY ADDITIONAL INFORMATION THAT MAY BE OBTAINED, WILL BE SENT IN A FOLLOW-UP WHEN AVAILABLE.
Description of Event or Problem
PT RECEIVED BURNS DURING IONTOPHORESIS. ELECTRODE PLACEMENT ON THE VEIL ZONE, RIGHT AND LEFT WRISTS FOR EPICONDYLITIS. BURN CLASSIFIED AS 3RD DEGREE. BURN OCCURRED ON 3RD TREATMENT. MEDICATION DELIVERED THROUGH TREATMENT WAS LIDOCAINE, 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 AND PROGRESS TOWARD RECOVERY WAS REPORTED AS IMPEDED. PATIENT REQUIRED LOCAL PHARMACOLOGIC MEDICAL INTERVENTION.