TRANSQ SM
Received Jul 2, 2009 · Event occurred Mar 23, 2009
Report 1721293-2009-00002 · MDR key 1410596
Product problems
- Insufficient Device Problem Information
Patient
58 YR
- Superficial (First Degree) Burn
Narrative
Description of Event or Problem
PT RECEIVED BURNS DURING IONTOPHORESIS STIMULATION TREATMENT. BURNS CLASSIFIED AS 1ST DEGREE. ELECTRODE PLACEMENT WAS TO RIGHT SHOULDER FOR TENDINITIS OF THE ROTATOR BONNET. MEDICATION DELIVERED THROUGH TREATMENT WAS KETOPROFEN - DOSAGE WAS 2.0CC. PATIENT IS REPORTED AS HAVING NO PREEXISTING CONDITIONS. TREATMENT PARAMETERS WERE NOT DISCLOSED. REPORTED GEL SEPARATING FROM ELECTRODE WHEN PROTECTIVE SHIELD IS PULLED FROM THE ELECTRODE. TREATMENT WAS NOT INTERRUPTED AND PROGRESS TOWARD RECOVERY WAS NOT INTERRUPTED. PATIENT'S BURN REQUIRED "LOCAL PHARMACOLOGICAL TREATMENT".
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.