BASED ON THE INFORMATION PROVIDED WE ARE UNABLE TO DETERMINE TO WHAT EXTENT IF ANY, THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT POST OPERATIVE PAIN AND SEROMA. THE ADVERSE EVENTS WERE ASSESSED AS POSSIBLY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. SEROMA IS A KNOWN INHERENT RISK OF SURGICAL PROCEDURES AND IS LISTED IN THE ADVERSE REACTION SECTION OF THE IFU AS A POSSIBLE COMPLICATION. SHOULD ADDITIONAL INFORMATION BE REPORTED REGARDING THE PATIENT'S CONDITION, A SUPPLEMENTAL MDR WILL BE SUBMITTED. THE INFORMATION PROVIDED BY BARD 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 BARD. DEVICE REMAINS IMPLANTED.
D
Patient 1
THE FOLLOWING WAS REPORTED AND IS ASSOCIATED WITH THE (B)(4). ON (B)(6) 2016 - THE PATIENT WAS IMPLANTED WITH A BARD XENMATRIX AB GRAFT FOR THE TREATMENT OF A RECURRENT VENTRAL INCISIONAL HERNIA. THE PROCEDURE INCLUDED A PARTIAL MESH (UNKNOWN) EXCISION AND EXTENSIVE LYSIS OF ADHESIONS. THE UNKNOWN MESH WAS REMOVED DUE TO THE EXTENT OF THE ADHESIONS. THE EXISTING HERNIA REPAIR WAS PERFORMED WITH A RETRO-RECTUS TECHNIQUE WITHOUT COMPONENT SEPARATION. THE HERNIA DEFECT WAS MEASURED WITH A LENGTH OF 25CM AND WIDTH OF 14CM. THE XENMATRIX AB GRAFT WAS TRIMMED PRIOR TO PLACEMENT. THERE WAS A GRAFT OVERLAP OF AT LEAST 5CM AROUND THE HERNIA DEFECT. THE HERNIA LOCATION IS LISTED TO HAVE ENCOMPASSED THE SUBXIPHOID, EPIGASTRIC, UMBILICAL AND INFRAUMBILICAL AREA. THE GRAFT WAS SUTURE FIXATED. A SURGICAL DRAIN WAS PLACED IN THE RIGHT LOWER QUADRANT, RECTO-RECTUS SPACE. ON (B)(6) 2016- THE PATIENT PRESENTED FOR HER THREE MONTH POSTOP VISIT. A 3CM X 3CM, SOFT NON TENDER SEROMA BELOW THE UMBILICUS WAS REVEALED. THERE WAS NO MEDICAL / SURGICAL INTERVENTION. THE SEROMA WAS ASSESSED AS POSSIBLY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. ON (B)(6) 2016 - THE PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN OF MODERATE SEVERITY. THE PAIN WAS ASSESSED AS POSSIBLY RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. THERE WAS NO ACTION TAKEN AND NO INTERVENTION REQUIRED. THERE WAS NO MENTION OF A SEROMA. ON (B)(6) 2016 - THE PATIENT WAS SEEN AT THE SIX MONTH POSTOP VISIT. THE PATIENT WAS ASSESSED TO HAVE A WELL HEALED MIDLINE SCAR. NON TENDER TO TOUCH. THE SEROMA HAD RESOLVED.