PHASIX MESH

Description of Event or Problem

PER INFORMATION PROVIDED: (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA AND VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC AND OPEN REPAIR WITH IMPLANT OF VENTRIO MESH (DEVICE 1, 2 AND 3). PER OP NOTES, ¿MULTIPLE ADHESIONS WERE TAKEN DOWN. TWO DIRECT HERNIA DEFECTS ON BOTH LEFT AND RIGHT INGUINAL REGIONS WERE NOTED AND REDUCED. TWO VENTRIO MESHES (DEVICE 1 ¿ LEFT AND DEVICE 2 - RIGHT) WERE PLACED AND TACKED. A VENTRAL INCISIONAL HERNIA SAC IN THE MIDLINE WAS NOTED AND EXCISED. A VENTRIO MESH (DEVICE 3) WAS PLACED AND SUTURED.¿ (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH INFECTED MESH THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL EXCISION OF VENTRIO MESH (DEVICE 3) AND IMPLANT OF PHASIX MESH (DEVICE 4). PER OP NOTES, ¿THE INFECTED PRIOR MESH (DEVICE 3) IN THE MIDLINE WAS NOTED WITH SEROMA. SEROMA WAS DRAINED. THE BOWEL ADHERENT TO MESH WAS TAKEN DOWN. INFECTED PART OF MESH (DEVICE 3) WAS EXCISED. A PHASIX MESH (DEVICE 4) WAS PLACED AND SUTURED.¿ (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH CELLULITIS AND NON-HEALING WOUND THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL EXCISION OF VENTRIO MESH (DEVICE 3) AND PHASIX (DEVICE 4). PER OP NOTES, ¿THE CELLULITIS WAS NOTED LOWER MIDLINE AND OPENED, THE SCAR TISSUE WAS EXCISED. THE RESIDUAL MESH (DEVICE 3 AND 4) WAS NOTED AND EXCISED. THE WOUND WAS DEBRIDED AND SUTURED.¿ (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH NONHEALING ABDOMINAL WOUND THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRIO MESH (DEVICE 3) AND PHASIX MESH (DEVICE 4). PER OP NOTES, ¿THE CHRONIC WOUND IN THE MID ABDOMEN WAS NOTED AND THE SCAR TISSUE WAS DEBRIDED. THE MESH (DEVICE 3 AND 4) WERE EXCISED ENTIRELY AND SUTURED.¿

Additional Manufacturer Narrative

ROOT CAUSE IS INCONCLUSIVE; NO CONCLUSION CAN BE MADE AS TO THE EXTENT TO WHICH THE IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE COURSE. THIS EMDR REPRESENTS THE BARD PHASIX MESH (DEVICE 4). ADDITIONAL SUPPLEMENTAL EMDR WERE SUBMITTED TO REPRESENT THE BARD VENTRIO MESH (DEVICE 1 AND DEVICE 3). 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.