PHASIX MESH

Description of Event or Problem

PER INFORMATION PROVIDED: (B)(6) 2010 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OPERATIVE NOTES, ¿IN THE MIDLINE, THREE DISCRETE DEFECTS IN A ROW WERE NOTED AND CONNECTED. THE FASCIA WAS CLOSED WITH SUTURES AND BARD FLAT MESH (DEVICE 1) WAS PLACED OVER THE DEFECT AND SECURED WITH SUTURES.¿ (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL REMOVAL OF PRIOR MESH (DEVICE 1) AND IMPLANT OF XENMATRIX AB MESH (DEVICE 2) AND PHASIX MESH (DEVICE 3). PER OPERATIVE NOTES, ¿IN THE MIDLINE, THE PRIOR MESH (DEVICE 1) WAS HARDENED AND FILL THE VENTRAL HERNIA. ADHESIONS WERE LYSED AND HERNIA ONE ABOVE AND BELOW THE BELLYBUTTON WERE REDUCED. THE PRIOR MESH (DEVICE 1) WAS PARTIALLY REMOVED AND ABSCESS WAS DRAINED. THE XENMATRIX AB MESH (DEVICE 2) WAS PLACED OVER THE FASCIA AND REAPPROXIMATED WITH SUTURES. THE FASCIA WAS REINFORCED AND PHASIX MESH (DEVICE 3) WAS PLACED AND SECURED WITH SUTURES AND OPTIFIX TACKERS.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH INFECTED WOUND THEREBY UNDERWENT INCISION AND DRAINAGE OF INFECTED WOUND AND SEROMA. PER OPERATIVE NOTES, ¿THE INFECTED SEROMA WAS DRAINED, AND FASCIA WAS IRRIGATED AND REAPPROXIMATED WITH SUTURES.¿ (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH INFECTED ANTERIOR ABDOMINAL WALL WOUND THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF PRIOR INFECTED MESHES (DEVICE 1, 2 AND 3). PER OPERATIVE NOTES, ¿THE NECROTIZED TISSUES WITH MESHES (DEVICE 1, 2 AND 3) IN ANTERIOR ABDOMINAL WALL WERE GRASPED FROM EDGES AND REMOVED. THE AREA WAS IRRIGATED AND WOUND VAC WAS PLACED.¿

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-MAY-2016) IS CONSIDERED TO BE A BEST ESTIMATE. THIS MDR REPRESENTS THE PHASIX MESH (DEVICE 3). AN ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT THE BARD FLAT MESH (DEVICE 1). AN ADDITIONAL MDR WAS SUBMITTED TO REPRESENT THE XENMATRIX AB MESH (DEVICE 2). 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.