TRANSQ MED
Received Jul 2, 2009 · Event occurred Mar 9, 2009
Report 1721293-2009-00004 · MDR key 1410599
Product problems
- Insufficient Device Problem Information
Patient
65 YR
- Superficial (First Degree) Burn
Narrative
Description of Event or Problem
PT RECEIVED BURNS DURING IONTOPHORESIS STIMULATION TREATMENT FOR METACARPUS TRAPEZE HEMARTROSIS. BURNS CLASSIFIED AS 1ST DEGREE. ELECTRODE PLACEMENT WAS TO 1 DEGREE DORSAL ZONE, LEFT HAND. MEDICATION DELIVERED THROUGH TREATMENT WAS LIDOCAINE 2% (3 SESSIONS) AND BETAMETHASONE (2 TREATMENTS), DOSAGE 2.0CC. PATIENT IS REPORTED AS HAVING NO PREEXISTING CONDITIONS. THE WAVE FORM USED FOR TREATMENT WAS CONSTANT CURRENT. INTENSITY WAS NOT DISCLOSED. TREATMENT WAS INTERRUPTED, BUT PROGRESS TOWARD RECOVERY WAS NOT IMPEDED. PT DID NOT REQUIRE FURTHER MEDICAL 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.