PHASIX MESH

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. NOTE, THE MANUFACTURING DATE (15-JUL-2017) IS CONSIDERED TO BE A BEST ESTIMATE. THIS MDR REPRESENTS THE PHASIX MESH (DEVICE 2). AN ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT THE VENTRALEX ST MESH (DEVICE 1). 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

PER INFORMATION PROVIDED: ON (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST (DEVICE 1). PER OP NOTES, ¿LAPAROSCOPIC APPENDECTOMY WAS DONE. AN UMBILICAL HERNIA WAS NOTED ALONG WITH ANOTHER SMALL HERNIA WERE COALESCED INTO ONE DEFECT. A VENTRALEX ST MESH (DEVICE 1) WAS PLACED INTO ABDOMEN AND SUTURED.¿ ON (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA; SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PHASIX MESH (DEVICE 2). PER OP NOTES, ¿THE ABDOMINAL HERNIA WAS NOTED. ADHESIONS WERE TAKEN DOWN. A PHASIX MESH (DEVICE 2) WAS PLACED OVER THE DEFECT USING SUTURES.¿ (NOTE: THERE IS NO MENTION/VISUALIZATION OF DEVICE 1 IN THIS PROCEDURE.) ON (B)(6) 2019 ¿ PATIENT WAS DIAGNOSED WITH REDUCIBLE RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1, 2) AND IMPLANT OF VENTRALEX ST MESH (DEVICE 3). PER OP NOTES, ¿THE FASCIAL DEFECT WAS IDENTIFIED. THE ADHESIONS WERE TAKEN DOWN. THE PREVIOUS MESH (DEVICE 1 AND 2) WAS REMOVED. A VENTRALEX ST MESH (DEVICE 3) WAS PLACED INTO THE ABDOMINAL CAVITY AND SECURED USING SUTURES.¿