GALAFORM¿ SCAFFOLD 3D

Additional Manufacturer Narrative

A REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO AND MET ALL SPECIFICATIONS AND THE STERILIZATION CYCLE MET VALIDATED PARAMETERS. NO CONCLUSION CAN BE MADE. AS REPORTED, THE REASON FOR THE MYCOBACTERIUM INFECTION COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. M. ABSCESSUS IS A BACTERIUM PART OF A GROUP OF ENVIRONMENTAL MYCOBACTERIA AND IS FOUND IN WATER, SOIL, AND DUST. IT HAS BEEN KNOWN TO CONTAMINATE MEDICATIONS AND PRODUCTS, INCLUDING MEDICAL DEVICES. M. ABSCESSUS CAN CAUSE A VARIETY OF INFECTIONS. HEALTHCARE-ASSOCIATED INFECTIONS DUE TO THIS BACTERIUM ARE USUALLY OF THE SKIN AND THE SOFT TISSUES UNDER THE SKIN. PEOPLE WITH OPEN WOUNDS OR WHO RECEIVE INJECTIONS WITHOUT APPROPRIATE SKIN DISINFECTION MAY BE AT RISK FOR INFECTION BY M. ABSCESSUS. AT THIS TIME, WE ARE UNABLE TO DETERMINE TO WHAT DEGREE, IF ANY, THE MESH IMPLANT USED ON THE PATIENT MAY HAVE CAUSED OR CONTRIBUTED THE PATIENT'S CONDITION. INFECTION IS A KNOWN INHERENT RISK OF SURGERY WITH OR WITHOUT THE USE OF MESH. IF ADDITIONAL INFORMATION IS PROVIDED, AN EMDR WILL BE SUBMITTED. TEPHA HAS MADE SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER THE REPORTER / COMPLAINANT WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER INFORMATION ON THE PATIENT, PRODUCT OR PROCEDURAL DETAILS.

Description of Event or Problem

DOCTOR STATED THE PATIENT DEVELOPED A "MYCOBACTERIUM ABSCESSUS" INFECTION AFTER THE INITIAL SURGERY AND HAD TO BE ON STEROIDS AND ANTIBIOTICS FOR 6 MONTHS. HE REMOVED THE MESH AND THE INFECTION CAME BACK AGAIN. NO ADDITIONAL INFORMATION PROVIDED.