CHATTANOOGA
Received Nov 9, 2015 · Event occurred Oct 6, 2015
Report 9616086-2015-00028 · MDR key 5212279
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Full thickness (Third Degree) Burn
Narrative
Additional Manufacturer Narrative
NOT RETURNED.
Description of Event or Problem
COMPLAINT RECEIVED THAT ALLEGES "THE UNIT HAS BURNED A PATIENT". PRODUCT NOT RETURNED FOR EVALUATION. PRODUCT QUESTIONNAIRE RECEIVED FROM CLINICIAN AND/OR PATIENT. EVENT DID INTERRUPT TREATMENT, RECOVERY WAS IMPEDED. PATIENT RECEIVED THIRD DEGREE BURN UNDER 1 ELECTRODE, SUPERFICIAL BURN UNDER ONE ELECTRODE. PATIENT RECEIVED TREATMENT AT THE TIME OF THE INCIDENT, AND WAS REFERRED FOR FOLLOW UP WITH DOCTOR POST EVENT.
Additional Manufacturer Narrative
PRODUCT WAS RETURNED FOR REVIEW. THE PRODUCT MALFUNCTIONED OR FAILED TO MEET SPECIFICATIONS. THE MALFUNCTION OR FAILURE IS NOT RELATED TO THE EVENT. NO PROBLEMS WERE DUPLICATED THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. ALL TREATMENTS WERE RUN FOR FULL DURATION AND NO PROBLEMS WERE DUPLICATED.