SEROMA FORMATION IS A KNOWN INHERENT RISK OF ANY SURGICAL PROCEDURE AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE IFU AS A POTENTIAL COMPLICATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. BASED ON THE INFORMATION PROVIDE, THE PATIENT DEVELOPED A POST OPERATIVE SEROMA WHICH WAS DRAINED AND HAS NOT RECURRED. THE STUDY MD HAS ASSESSED THE SEROMA TO BE POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. NO DEFINITIVE CONCLUSION CAN BE MADE AT THIS TIME. IF ADDITIONAL INFORMATION IS PROVIDED, 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. REMAINS IMPLANTED.
D
Patient 1
IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED A POST OPERATIVE SEROMA. ON (B)(6) 2016 - THE PATIENT UNDERWENT THE REPAIR OF A RECURRENT VENTRAL INCISIONAL HERNIA WITH BILATERAL POSTERIOR COMPONENT SEPARATION, BILATERAL TRANSVERSE ABDOMINUS RELEASE, PLACEMENT OF A BARD XENMATRIX AB GRAFT, REMOVAL OF RETAINED GALLBLADDER TISSUE AND GALLSTONES. ON (B)(6) 2017 - THE PATIENT CALLED THE STUDY MD WITH COMPLAINTS OF PAIN AT THE INCISION SITE OF A PRIOR DRAIN AND STATED THE PAIN WAS "PULSING" AND SEVERE, HOWEVER, DID NOT RADIATE. THE PATIENT STATED THAT THE PAIN WAS NOT ALLEVIATED 1 HOUR AFTER TAKING OXYCODONE. THE PATIENT PRESENTED TO HIS LOCAL HOSPITAL AND UNDERWENT ASPIRATION OF A FLUID COLLECTION (SEROMA). THE FLUID WAS REPORTED TO HAVE NOT BEEN INFECTED. ON (B)(6) 2017 - THE PATIENT PRESENTED FOR 6 WEEK POST OP VISIT AND STATES THAT THERE HAD BEEN NO RECURRENCE OF THE FLUID COLLECTION. THE PATIENT HAD NO OTHER COMPLAINTS. THE STUDY MD HAS ASSESSED THE SEROMA TO BE POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE.
N
Patient 1
THIS IS AN ADDENDUM TO THE INITIAL MDR TO DOCUMENT ADDITIONAL MEDICAL TREATMENT PROVIDED TO THE PATIENT. THIS TREATMENT WAS REPORTED TO BE ASSOCIATED TO A CASCADING EVENT STEMMING FROM THE PREVIOUSLY REPORTED SEROMA. THE STUDY MD HAS ASSESSED THIS EVENT TO BE POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. NO DEFINITIVE CONCLUSION CAN BE MADE AT THIS TIME. IF ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.
D
Patient 1
IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED A POST OPERATIVE SEROMA. ON (B)(6) 2016 - THE PATIENT UNDERWENT THE REPAIR OF A RECURRENT VENTRAL INCISIONAL HERNIA WITH BILATERAL POSTERIOR COMPONENT SEPARATION, BILATERAL TRANSVERSE ABDOMINUS RELEASE, PLACEMENT OF A BARD XENMATRIX AB GRAFT, REMOVAL OF RETAINED GALLBLADDER TISSUE AND GALLSTONES. ON (B)(6) 2017 - THE PATIENT CALLED THE STUDY MD WITH COMPLAINTS OF PAIN AT THE INCISION SITE OF A PRIOR DRAIN AND STATED THE PAIN WAS "PULSING" AND SEVERE, HOWEVER, DID NOT RADIATE. THE PATIENT STATED THAT THE PAIN WAS NOT ALLEVIATED 1 HOUR AFTER TAKING OXYCODONE. THE PATIENT PRESENTED TO HIS LOCAL HOSPITAL AND UNDERWENT ASPIRATION OF A FLUID COLLECTION (SEROMA). THE FLUID WAS REPORTED TO HAVE NOT BEEN INFECTED. ON (B)(6) 2017 - THE PATIENT PRESENTED FOR 6 WEEK POST OP VISIT AND STATES THAT THERE HAD BEEN NO RECURRENCE OF THE FLUID COLLECTION. THE PATIENT HAD NO OTHER COMPLAINTS. THE STUDY MD HAS ASSESSED THE SEROMA TO BE POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THIS IS AN ADDENDUM TO THE INITIAL MDR. ON (B)(6) 2017 - THE PATIENT PRESENTED FOR THREE MONTH FOLLOW UP VISIT WITH REPORT THAT THE INFERIOR ASPECT OF HIS MIDLINE INCISION HAS OPENED UP SINCE THE ASPIRATION OF HIS SEROMA. IT OCCASIONALLY DRAINS SOME SEROSANGUINOUS FLUID. UPON EXAM THE MD NOTES THE MIDLINE INCISION IS MOSTLY HEALED WITH INFERIOR OPENING DUE TO EPITHELIALIZED TRACT FROM PRIOR SEROMA, NO ERYTHEMA (SOME IRRITATION FROM TAPE), NO WARMTH, MINIMAL SEROSANGUINOUS DRAINAGE WITH NO EVIDENCE OF HERNIA RECURRENCE. PATIENT WILL FOLLOW UP WITH A WOUND CLINIC FOR TWICE WEEKLY SILVER NITRATE APPLICATIONS WITH WOUND PACKING UNTIL IT HAS HEALED. SURGEON ASSESSED THIS EVENT AS A GRADE 1 CLINICAL SEVERITY, NOT SERIOUS, POSSIBLY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THE STUDY NOTES THERE WAS NO INTERVENTION REQUIRED AND THE PATIENT IS RECOVERING.