PHASIX MESH

Description of Event or Problem

AS REPORTED, THE PATIENT UNDERWENT A ROBOTIC TAPP PROCEDURE WITH A PHASIX MESH ON (B)(6) 2025. THREE DAYS POST IMPLANT THE PATIENT DEVELOPED A RASH IN THE ABDOMINAL AND LEG AREA AND HAS SINCE VISITED THE EMERGENCY ROOM MULTIPLE TIMES. THE PATIENT WAS GIVEN STEROIDS FOR THE RASH WHICH HELPED IMPROVE THE RASH TO SOME EXTENT, BUT THE RASH CAME BACK. THE PATIENT HAS NO OTHER SYMPTOMS. THE PATIENT HAS BEEN PRESCRIBED STEROIDS AND ANTIHISTAMINES, NO OTHER TREATMENT PLAN AT THIS TIME.

Additional Manufacturer Narrative

AS REPORTED, THE PATIENT DEVELOPED A RASH THREE DAYS POST IMPLANT OF PHASIX FLAT MESH. BASED ON THE INFORMATION PROVIDED, NO CONCLUSION CAN BE MADE AS TO THE DEGREE TO WHICH THE IMPLANT MAY BE CAUSING OR CONTRIBUTING TO THE POSTOPERATIVE RASH. THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE LISTS ALLERGIC REACTION AS A POSSIBLE COMPLICATION. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF 144 UNITS RELEASED FOR DISTRIBUTION. NOTE, THE DATE OF EVENT IS ESTIMATED BASED ON INFORMATION PROVIDED. 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.