AVITENE ULTRAFOAM

Additional Manufacturer Narrative

AS REPORTED, AN AVITENE ULTRAFOAM ALLEGEDLY HAD A FOREIGN MATERIAL (SMALL BROWN COLOR) ON THE SURFACE OF THE PRODUCT IN THE INNER STERILE PACKAGE; DISCOVERED PRIOR TO USE. THE MESH IS BEING RETURNED FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. PHOTOS AND VIDEO PROVIDED CONFIRMING, THERE IS A SMALL AREA OF DISCOLORATION (BROWN IN COLOR) PRESENT ON THE ULTRAFOAM. PHOTOS/VIDEO DO NOT ASSIST IN DETERMINING ROOT CAUSE. BASED ON THE INFORMATION PROVIDED AND NOT HAVING THE PHYSICAL SAMPLE TO EVALUATE AT THIS TIME NO CONCLUSIONS CAN BE MADE. IF/WHEN THE SAMPLE IS RETURNED AND EVALUATED A SUPPLEMENTAL MDR WILL BE SUBMITTED TO DOCUMENT THE EVALUATION RESULTS. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS. ADDENDUM: THIS IS AN ADDENDUM TO THE INITIAL MDR SUBMITTED. THIS SUPPLEMENTAL MDR IS SUBMITTED TO DOCUMENT THE RESULTS OF SAMPLE EVALUATION. VISUAL INSPECTION IDENTIFIED TWO EMBEDDED FOREIGN MATERIALS IN THE FINISHED PRODUCT BROWN IN COLOR. AS IT COULD NOT BE DETERMINED WHETHER THE MATERIAL WAS TRUE FOREIGN CONTAMINATION OR DISCOLORED FLOUR, THE SAMPLE WAS SENT FOR FURTHER IDENTIFICATION TESTING. THE SAMPLE UNDERWENT OPTICAL MICROSCOPY (OM) AND IMAGING MICRO-FOURIER TRANSFORM INFRARED SPECTROSCOPY (IFTIR) AT AN EXTERNAL LABORATORY. TESTING CONFIRMED THAT THE BROWN FRAGMENTS WERE CHITIN, EXHIBITING MORPHOLOGY CONSISTENT WITH INSECT FRAGMENTS. BASED ON THE INVESTIGATIONAL ACTIVES PERFORMED THE FRAGMENTS ARE FOUND TO HAVE PRESENTED AT SOME POINT DURING THE MANUFACTURING PROCESS. WHEN OR HOW DURING THE PROCESS THE FRAGMENTS PRESENTED CANNOT BE DETERMINED AT THIS TIME. ACTIONS ARE BEING TAKEN TO FURTHER INVESTIGATE. UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H6, H10. 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, AN AVITENE ULTRAFOAM ALLEGEDLY HAD A FOREIGN MATERIAL (SMALL BROWN COLOR) ON THE SURFACE OF THE PRODUCT IN THE INNER STERILE PACKAGE; DISCOVERED PRIOR TO USE. THE OUTER PACKAGING WAS INTACT, AND THE INNER PACKAGING WAS COMPLETELY SEALED BEFORE OPENING. THE ULTRAFOAM WAS NOT USED AND THERE WAS NO PATIENT INJURY.

Description of Event or Problem

AS REPORTED, AN AVITENE ULTRAFOAM ALLEGEDLY HAD A FOREIGN MATERIAL (SMALL BROWN COLOR) ON THE SURFACE OF THE PRODUCT IN THE INNER STERILE PACKAGE; DISCOVERED PRIOR TO USE. THE OUTER PACKAGING WAS INTACT, AND THE INNER PACKAGING WAS COMPLETELY SEALED BEFORE OPENING. THE ULTRAFOAM WAS NOT USED AND THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

AS REPORTED, AN AVITENE ULTRAFOAM ALLEGEDLY HAD A FOREIGN MATERIAL (SMALL BROWN COLOR) ON THE SURFACE OF THE PRODUCT IN THE INNER STERILE PACKAGE; DISCOVERED PRIOR TO USE. THE MESH IS BEING RETURNED FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. PHOTOS AND VIDEO PROVIDED CONFIRMING, THERE IS A SMALL AREA OF DISCOLORATION (BROWN IN COLOR) PRESENT ON THE ULTRAFOAM. PHOTOS/VIDEO DO NOT ASSIST IN DETERMINING ROOT CAUSE. BASED ON THE INFORMATION PROVIDED AND NOT HAVING THE PHYSICAL SAMPLE TO EVALUATE AT THIS TIME NO CONCLUSIONS CAN BE MADE. IF/WHEN THE SAMPLE IS RETURNED AND EVALUATED A SUPPLEMENTAL MDR WILL BE SUBMITTED TO DOCUMENT THE EVALUATION RESULTS. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS. ADDENDUM 1: THIS IS AN ADDENDUM TO THE INITIAL MDR SUBMITTED. THIS SUPPLEMENTAL MDR IS SUBMITTED TO DOCUMENT THE RESULTS OF SAMPLE EVALUATION. VISUAL INSPECTION IDENTIFIED TWO EMBEDDED FOREIGN MATERIALS IN THE FINISHED PRODUCT BROWN IN COLOR. AS IT COULD NOT BE DETERMINED WHETHER THE MATERIAL WAS TRUE FOREIGN CONTAMINATION OR DISCOLORED FLOUR, THE SAMPLE WAS SENT FOR FURTHER IDENTIFICATION TESTING. THE SAMPLE UNDERWENT OPTICAL MICROSCOPY (OM) AND IMAGING MICRO-FOURIER TRANSFORM INFRARED SPECTROSCOPY (IFTIR) AT AN EXTERNAL LABORATORY. TESTING CONFIRMED THAT THE BROWN FRAGMENTS WERE CHITIN, EXHIBITING MORPHOLOGY CONSISTENT WITH INSECT FRAGMENTS. BASED ON THE INVESTIGATIONAL ACTIVES PERFORMED THE FRAGMENTS ARE FOUND TO HAVE PRESENTED AT SOME POINT DURING THE MANUFACTURING PROCESS. WHEN OR HOW DURING THE PROCESS THE FRAGMENTS PRESENTED CANNOT BE DETERMINED AT THIS TIME. ACTIONS ARE BEING TAKEN TO FURTHER INVESTIGATE. ADDENDUM 2: THIS IS AN ADDENDUM TO THE INITIAL MDR SUBMITTED. THIS SUPPLEMENTAL MDR IS SUBMITTED TO DOCUMENT THE FIELD ACTION THAT WAS UNDERTAKEN AND REPORTED TO FDA. REF. FIELD ACTION REPORT NUMBER 1213643-03/13/2026-001-C. THE ACTION IS STILL UNDER REVIEW FOR RECALL CLASSIFICATION AND FDA HAS NOT COMPLETED CLASSIFICATION. 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, AN AVITENE ULTRAFOAM ALLEGEDLY HAD A FOREIGN MATERIAL (SMALL BROWN COLOR) ON THE SURFACE OF THE PRODUCT IN THE INNER STERILE PACKAGE; DISCOVERED PRIOR TO USE. THE OUTER PACKAGING WAS INTACT, AND THE INNER PACKAGING WAS COMPLETELY SEALED BEFORE OPENING. THE ULTRAFOAM WAS NOT USED AND THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

AS REPORTED, AN AVITENE ULTRAFOAM ALLEGEDLY HAD A FOREIGN MATERIAL (SMALL BROWN COLOR) ON THE SURFACE OF THE PRODUCT IN THE INNER STERILE PACKAGE; DISCOVERED PRIOR TO USE. THE MESH IS BEING RETURNED FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. PHOTOS AND VIDEO PROVIDED CONFIRMING, THERE IS A SMALL AREA OF DISCOLORATION (BROWN IN COLOR) PRESENT ON THE ULTRAFOAM. PHOTOS/VIDEO DO NOT ASSIST IN DETERMINING ROOT CAUSE. BASED ON THE INFORMATION PROVIDED AND NOT HAVING THE PHYSICAL SAMPLE TO EVALUATE AT THIS TIME NO CONCLUSIONS CAN BE MADE. IF/WHEN THE SAMPLE IS RETURNED AND EVALUATED A SUPPLEMENTAL MDR WILL BE SUBMITTED TO DOCUMENT THE EVALUATION RESULTS. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS. 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.