AVITENE

Additional Manufacturer Narrative

AS REPORTED, A BLACK SPOT WAS FOUND IN THE AVITENE PRODUCT PRIOR TO USE. THE SAMPLE WAS REQUESTED TO BE RETURNED AND IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, AT THIS TIME IT HAS NOT BEEN RECEIVED. BASED ON THE INFORMATION AVAILABLE AND WITHOUT HAVING THE SAMPLE TO EVALUATE, NO CONCLUSIONS CAN BE MADE. A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. IF/WHEN THE SAMPLE IS RETURNED AND EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL MDR WILL BE SUBMITTED TO DOCUMENT THE RESULTS. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

AS REPORTED, A BLACK SPOT WAS FOUND IN THE AVITENE PRODUCT DURING ATTEMPTED USE. THERE WAS NO REPORTED PATIENT INJURY.