GALAFLEX LITE

Additional Manufacturer Narrative

AS REPORTED, DURING A BREAST RECONSTRUCTION PROCEDURE AFTER MASTECTOMY, A "HAIR" WAS FOUND IN THE GALAFLEX LITE PACKAGING. BASED ON THE PHOTO PROVIDED AND SAMPLE EVALUATION, FOREIGN MATERIAL (EYEBROW HAIR-LIKE) WAS OBSERVED ON TOP OF THE INNER STERILE ENVELOPE OF GALAFLEX LITE. THE HAIR MAY BE PRESENTED DURING THE MANUFACTURING PROCESS OR AT THE TIME THE STERILE PACK WAS OPENED. BASED ON THE EVENT REPORTED AND SAMPLE CONDITION THE MOST PROBABLE CAUSE OF HAIR PRESENTING IS DURING MANUFACTURING. REVIEW OF MANUFACTURING RECORDS CONFIRMS THE 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.

Description of Event or Problem

AS REPORTED, DURING A BREAST RECONSTRUCTION PROCEDURE AFTER MASTECTOMY, A "HAIR" WAS FOUND IN THE GALAFLEX LITE PACKAGING. ANOTHER PRODUCT WAS USED FOR THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY.