PHASIX MESH

Description of Event or Problem

PER INFORMATION PROVIDED: (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA, OPEN WOUND TO THE ABDOMEN THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALIGHT ST (DEVICE #1) & PHASIX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿A SMALL PIECE OF VENTRALIGHT ST (DEVICE #1) WAS PLACED AGAINST THE BOWEL AND A PIECE OF PHASIX MESH (DEVICE #2) WAS TACKED AS AN INTERNAL CORSET.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH ANTERIOR ABDOMINAL WALL ABSCESS AND SUPERFICIAL WOUND INFECTION, INFECTED MESH THEREBY UNDERWENT REMOVAL OF MESHES (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿PATIENT WHO PRESENTED SEPTIC WITH INFECTION IN THE ABDOMINAL WALL AND HE WAS RESUSCITATED IN THE ICU. PATIENT WAS PRESENTED WITH A LARGE SUBCUTANEOUS ABSCESS. THE MESHES WERE REMOVED (DEVICE #1 & #2).¿ ATTORNEY ALLEGED THAT THE PATIENT HAD ABSCESS, HERNIA RECURRENCE, INFECTION, PAIN AND SUFFERING. IT WAS ALSO ALLEGED THAT PATIENT HAD WOUND VAC, SEPSIS AND UNINCORPORATED MESH.

Additional Manufacturer Narrative

BASED ON THE INFORMATION RECEIVED, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT 4 MONTHS POST IMPLANT OF PHASIX MESH, PATIENT WAS DIAGNOSED WITH SEPSIS, WOUND INFECTION AND ABSCESS THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LIST INFECTION AS A POSSIBLE COMPLICATION. IN REGARD TO INFECTION, THE WARNINGS SECTION IN IFU STATES, "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. CONSIDERATION SHOULD BE GIVEN REGARDING THE NEED TO REMOVE THE MESH. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE DEVICE". NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. THIS EMDR REPRESENTS THE PHASIX MESH (DEVICE #2). AN ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT THE VENTRALIGHT 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.