FLEXCELL

Additional Manufacturer Narrative

INFINITE BIOMEDICAL TECHNOLOGIES IS SUBMITTING THE INFORMATION TO COMPLY BY 21 CFR 803. THIS REPORT IS BASED ON THE INFORMATION RECEIVED BY INFINITE BIOMEDICAL TECHNOLOGIES LLC (REFFERED TO AS IBT HEREAFTER), WHICH THE COMPANY MAY HAVE NOT BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. IBT HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. NOTE: H4: DEVICE MANUFACTURER DATE: THE DEVICE MANUFACTURING DATE ADDED IS BASED ON THE INFORMATION AVAILABLE WITH THE MANUFACTURER FROM THE TIME WHEN THE FLEXCELL KIT WAS SOLD AND SHIPPED. FOLLOWING ARE THE SECTIONS THAT IBT IS CURRENTLY WORKING ON TO OBTAIN MORE INFORMATION ON: A5: ETHNICITY.

Description of Event or Problem

EVENT: PROSTHETIST REPORTED THAT PATIENT WAS DRIVING TO THE PROSTHETISTS OFFICE, AND THE PROSTHESIS WAS PUT ON CHARGING VIA CAR CHARGER IN THE SEAT NEXT TO HIM. ABOUT 10 MINUTES LATER, THE PATIENT SMELLED SMOKE AND DISCONNECTED THE CHARGER. THE PROSTHESIS WAS DISASSEMBLED AT THE CLINIC, AND WAS OBSERVED THAT 1 OF THE 4 BATTERIES WERE DAMAGED. THERE WAS NO PATIENT INJURY INVOLVED.

Additional Manufacturer Narrative

INFINITE BIOMEDICAL TECHNOLOGIES IS SUBMITTING THE INFORMATION TO COMPLY BY 21 CFR 803. THIS REPORT IS BASED ON THE INFORMATION RECEIVED BY INFINITE BIOMEDICAL TECHNOLOGIES LLC (REFEREED TO AS IBT HEREAFTER), WHICH THE COMPANY MAY HAVE NOT BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. IBT HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT.