ME994 SONICATOR PLUS
Received Jun 28, 2011 · Event occurred Feb 10, 2011
Report 2013558-2011-00002 · MDR key 2154147
Device
Generic name
Muscle Stimulator & Ultrasound Therapy
Manufacturer
Mettler Electronics Corp.Model number
ME994Catalog number
ME994
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
14 YR
- Erythema
- Burn, Thermal
Narrative
Description of Event or Problem
ON (B)(6) 2011, I RECEIVED A MAILING FROM THE DEPT OF HEALTH & HUMAN SERVICES/FDA. ENCLOSED WITHIN THE MAILING WAS A MEDWATCH REPORT THAT WAS SUBMITTED BY (B)(6) HOSP C/O: (B)(6). UPON READING THE LETTER IT WAS NOTICED THAT AN ALLEGED INCIDENT HAPPENED USING A METTLER SONICATOR PLUS ME994 DEVICE SERIAL NUMBER (B)(4). AFTER REVIEW OF DOCUMENT HISTORY ON THIS DEVICE, IT WAS NOTICED THAT THIS DEVICE WAS RECEIVED AT METTLER ON (B)(6) 2011 - FOR A REQUEST OF "CALIBRATION" BY (B)(6) HOSP - THERE WAS NO MENTION OF A PT INCIDENT. METTLER SVC DEPT CHECKED THE DEVICE, PER (B)(4), AND MADE THE NECESSARY REPAIRS AND UPGRADES. THE DEVICE WAS RETURNED TO THE CUSTOMER ON (B)(6) 2011 (B)(4). INITIAL REPORT STATED THE ELECTRODES WERE PLACED ON PT'S RIGHT ARM AND DURING TREATMENT PT'S SKIN TURNED RED IN THREE OUT OF THE FOUR ELECTRODE PLACES. THE FOLLOWING WEEK THE PT RETURNED WITH THREE BURN MARKS. MOTHER HAD REPORTED TO PLACING OIL ON PT'S SKIN PRIOR TO THE VISIT.
Additional Manufacturer Narrative
ON (B)(6) 2011, (B)(6) 2011 AND (B)(6) 2011, I ATTEMPTED TO CONTACT (B)(6), OF (B)(6) HOSP, TO GET MORE DETAILS OF THE ALLEGED INCIDENT. I LEFT MESSAGES EACH TIME, ASKING HER TO RETURN MY CALL. ON (B)(6) 2011 (AT 12:15) SHE RETURNED MY CALL AND THUS THE DELAY IN SUBMITTED MY INITIAL REPORT.