ME294 SYS STIM
Received Sep 23, 2010
Report 2013558-2010-00005 · MDR key 1845803
Device
Generic name
Muscle Stimulator
Manufacturer
Mettler Electronics Corp.Model number
ME294Catalog number
ME294
Product problems
- Insufficient Device Problem Information
Patient
UNK
- Fluid Discharge
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
PER THE PHYSIOTHERAPIST AT (B)(6) REHAB HE CLAIMS THAT HAD TWO PATIENTS THAT RECEIVED BURNS FROM THIS UNIT. THE ALLEGED BURNS WERE QUARTER SIZED. ONE PATIENT HAD MULTIPLE BURNS AND THE OTHER PATIENT HAD ONLY A SINGLE BURN. BOTH BURNS BLISTERED, BROKE AND PUSSED - REQUIRING EXTRA MEDICAL ATTENTION.
Additional Manufacturer Narrative
PER MR. (B)(6), THE PHYSIOTHERAPIST THAT CONDUCTED THE TREATMENT ON BOTH PATIENTS, THE BLISTERS HAVE ALREADY HEALED FROM BOTH PATIENTS AND NO ONE IS SEEKING LITIGATION FROM EITHER INCIDENT. ON (B)(6)2010 - PER METTLER SERVICE TECHNICIAN - ENCODER TO CH. 1 WAS REPLACED BECAUSE THE INTENSITY WOULD NOT GO UP. THIS COULD NOT HAVE CAUSED BURNING TO PATIENTS. TECHNICIAN IS BURNING UNIT IN AND WILL RETEST AGAIN.