TRANSQ SM
Received Jul 2, 2009 · Event occurred Apr 27, 2009
Report 1721293-2009-00003 · MDR key 1410591
Product problems
- Insufficient Device Problem Information
Patient
41 YR
- Superficial (First Degree) Burn
Narrative
Description of Event or Problem
PT RECEIVED BURNS DURING IONTOPHORESIS STIMULATION TREATMENT FOR TENOSYNOVITIS OF THE EXTENSOR TENDON, FIRST FINGER. BURNS CLASSIFIED AS 1ST DEGREE. ELECTRODE PLACEMENT WAS TO 1 DEGREE RADIAL OF DOSAL ZONE, RIGHT HAND. MEDICATION DELIVERED THROUGH TREATMENT WAS KETOPROFEN - DOSAGE WAS 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'S BURN REQUIRED "LOCAL PHARMACOLOGICAL TREATMENT".
Additional Manufacturer Narrative
ANY ADDITIONAL INFORMATION THAT MAY BE OBTAINED, WILL BE SENT IN A FOLLOW-UP WHEN AVAILABLE.