LEG SENSOR V6 LEFT OR RIGHT TP
Received May 3, 2012 · Event occurred Apr 15, 2012
Report MW5025310 · MDR key 2565393
Device
Product problems
- Insufficient Device Problem Information
Patient
48 YR
- Burn(s)
Narrative
Description of Event or Problem
THREE PATIENTS RECEIVED BURNS ON LEGS AT THE SITE WHERE A LEG SENSOR WAS APPLIED DURING SLEEP STUDY TESTING. FIRST PATIENT AND SECOND PATIENT, (B)(6), NOTIFIED SLEEP CENTER OF BURNS ON (B)(6) 2012. DATE OF BURNS (B)(6) 2012. THIRD PATIENT NOTIFIED OFFICE DURING A FOLLOW UP VISIT ON (B)(6) 2012, (B)(6). THAT HE RECEIVED A BURN ON LEG WHEN IN FOR TESTING ON (B)(6) 2012. PICTURES FROM PATIENT, (B)(6), WERE FORWARDED TO SLEEP CENTER AND THERE APPEARED TO BE A RAISED BLISTER AT THE SITE OF WHERE LEG SENSORS WERE ATTACHED. NO MEDICAL TREATMENT WAS RECEIVED BY ANY OF THESE PATIENTS TO DETERMINE IF AN ALLERGIC REACTION OR CHEMICAL BURN MAY HAVE CAUSED BURN. ALSO SEE (B)(4).