PHASIX MESH

Additional Manufacturer Narrative

BASED ON THE INFORMATION RECEIVED, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT 2 YEARS 1 MONTH POST IMPLANT OF PHASIX MESH, PATIENT WAS DIAGNOSED WITH SEPSIS, CELLULITIS, ABSCESS, INFLAMMATION. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LIST INFLAMMATION AS A POSSIBLE COMPLICATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. NOTE, THE MANUFACTURING DATE (15-APR-2015) IS CONSIDERED TO BE A BEST ESTIMATE. THIS EMDR REPRESENTS THE PHASIX MESH (DEVICE #2). ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT THE VENTRIO ST (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 BY PATIENT¿S ATTORNEY: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS EXCISED. A VENTRIO ST MESH (DEVICE #1) WAS PLACED INTO THE ABDOMEN AND SUTURED.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA AND EXPLORATORY LAPAROTOMY THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF OLD MESH (DEVICE #1) AND IMPLANT OF PHASIX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE FASCIA WAS CLOSED UNDER THE SEROMA, GRASPED THE VENTRIO ST MESH (DEVICE #1) AND WERE ABLE TO PULL AWAY FROM THE ANTERIOR ABDOMINAL WALL. THE SEROMA WAS ENTIRELY DRAINED, AND THE MESH WAS REMOVED. ADHESIONS WERE TAKEN DOWN. A PHASIX MESH (DEVICE #2) WAS PLACED AND SUTURED.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH ABSCESS & SEPSIS, OPEN WOUND ABDOMINAL WALL THEREBY UNDERWENT EXCISION & DEBRIDEMENT OF SKIN AND SUBCUTANEOUS TISSUE TO FASCIA. PER OPERATIVE NOTES, ¿INCISING THE SKIN AND SUBCUTANEOUS TISSUE OVERLYING THE OPEN DRAINING WOUND AND AREA OF CELLULITIS. ALL CHRONICALLY INFLAMED TISSUE WAS REMOVED.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, PAIN, INFECTION, HERNIA RECURRENCE AND SEROMA. IT WAS ALSO ALLEGED THAT THE PATIENT HAD EXCISION AND DEBRIDEMENT OF NONVIABLE AND CHRONICALLY INFLAMED TISSUE AND WASHOUT OF ABDOMINAL WOUND.