FLEXCELL

Description of Event or Problem

PRACTITIONER CALLED INFINITE BIOMEDICAL TECHNOLOGIES (IBT) TO REPORT THAT ONE OF THE BATTERIES IN THE PROSTHESIS PUFFED UP AND THERE WAS SOME HEAT ASSOCIATED WITH THE INCIDENT. THE USER WAS WEARING THE PROSTHESIS AT THE TIME OF THE INCIDENT, FELT SOME PRESSURE AND WARMTH AND IMMEDIATELY TOOK THE PROSTHESIS OFF. THERE WAS NO USER 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 (REFERED TO AS IBT HEREAFTER), WHICH THE COMPANY MAY NOT HAVE 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.