TRANSQ SM
Received Jul 2, 2009 · Event occurred Mar 2, 2009
Report 1721293-2009-00009 · MDR key 1410622
Product problems
- Insufficient Device Problem Information
Patient
67 YR
- Superficial (First Degree) Burn
Narrative
Description of Event or Problem
PATIENT RECEIVED BURNS DURING IONTOPHORESIS. ELECTRODE PLACEMENT ON THE ANTERIOR ZONE OF THE SHOULDER FOR SUPRASPINATUS TENDINOPATHY. BURN CLASSIFIED AS 1ST DEGREE. BURN OCCURRED ON 3RD TREATMENT. MEDICATION DELIVERED THROUGH TREATMENT WAS LIDOCAINE 2% AND BETAMETHASONE. 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 DID NOT REQUIRE FURTHER 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.