PHASIX MESH

Description of Event or Problem

AS REPORTED PER CLINICAL TRIAL (B)(4): THE SUBJECT PATIENT UNDERWENT OPEN AND LAPAROSCOPIC COLECTOMY PROCEDURE ON (B)(6) 2024 DURING WHICH A TRIMMED PHASIX MESH WAS PLACED IN AN ONLAY FASHION AND SUTURED USING ABSORBABLE MONOFILAMENT 2.0 PDS SUTURES. A 3 CM OVERLAP IN ALL DIRECTIONS WAS ACHIEVED. THE SUBJECT PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT HAS BEEN DIAGNOSED WITH INCISIONAL ABSCESS REQUIRING DRAINAGE. THE SUBJECT PATIENT WAS READMITTED FOR PERIUMBILICAL ERYTHEMA AND PAIN WITH CT DEMONSTRATING SUBCUTANEOUS FLUID COLLECTION CONCERNING SEROMA THEREFORE IR DRAIN PLACED ON (B)(6) 2024 AND PROVIDED ANTIBIOTICS (IV VANCOMYCIN AND CLINDAMYCIN). PATIENT WAS HOSPITALIZED. THE REPORTED ADVERSE EVENT (INCISIONAL ABSCESS) HAS BEEN ASSESSED PER CLINICIAN AS PROBABLY RELATED TO THE STUDY DEVICE AND CAUSALLY RELATED TO THE PROCEDURE AND RECOVERED/RESOLVED. THE AE HAS BEEN ASSESSED AS MODERATE IN SEVERITY. THE REPORTED AE DOES MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE DEFINITION OF UADE (UNANTICIPATED ADVERSE DEVICE EVENT).

Additional Manufacturer Narrative

AS REPORTED, PATIENT DEVELOPED INCISIONAL ABSCESS AND SEROMA POST IMPLANT OF PHASIX MESH. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE COURSE OF INCISIONAL ABSCESS AND SEROMA AS PROBABLY RELATED TO THE STUDY DEVICE WITH CAUSAL RELATIONSHIP TO THE PROCEDURE. HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. SEROMA IS A CLINICALLY UNDERSTOOD POTENTIAL COMPLICATION OF SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE AS A POSSIBLE COMPLICATION. 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.

Additional Manufacturer Narrative

AS REPORTED, PATIENT DEVELOPED INCISIONAL ABSCESS AND SEROMA POST IMPLANT OF PHASIX MESH. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE COURSE OF INCISIONAL ABSCESS AND SEROMA AS PROBABLY RELATED TO THE STUDY DEVICE WITH CAUSAL RELATIONSHIP TO THE PROCEDURE. HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. SEROMA IS A CLINICALLY UNDERSTOOD POTENTIAL COMPLICATION OF SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE AS A POSSIBLE COMPLICATION. ADDENDUM: H11: THIS SUPPLEMENTAL MDR IS SUBMITTED TO UPDATE THE DHR RESULTS AND TO CORRECT THE UDI. REVIEW OF MANUFACTURING RECORDS SHOWS PRODUCT WAS MADE TO SPECIFICATION. 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

AS REPORTED PER CLINICAL TRIAL (B)(4)): THE SUBJECT PATIENT UNDERWENT OPEN AND LAPAROSCOPIC COLECTOMY PROCEDURE ON (B)(6)2024 DURING WHICH A TRIMMED PHASIX MESH WAS PLACED IN AN ONLAY FASHION AND SUTURED USING ABSORBABLE MONOFILAMENT 2.0 PDS SUTURES. A 3 CM OVERLAP IN ALL DIRECTIONS WAS ACHIEVED. THE SUBJECT PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6)2024. ON (B)(6)2024, THE PATIENT HAS BEEN DIAGNOSED WITH INCISIONAL ABSCESS REQUIRING DRAINAGE. THE SUBJECT PATIENT WAS READMITTED FOR PERIUMBILICAL ERYTHEMA AND PAIN WITH CT DEMONSTRATING SUBCUTANEOUS FLUID COLLECTION CONCERNING SEROMA THEREFORE IR DRAIN PLACED ON (B)(6)2024 AND PROVIDED ANTIBIOTICS (IV VANCOMYCIN AND CLINDAMYCIN). PATIENT WAS HOSPITALIZED. THE REPORTED ADVERSE EVENT (INCISIONAL ABSCESS) HAS BEEN ASSESSED PER CLINICIAN AS PROBABLY RELATED TO THE STUDY DEVICE AND CAUSALLY RELATED TO THE PROCEDURE AND RECOVERED/RESOLVED. THE AE HAS BEEN ASSESSED AS MODERATE IN SEVERITY. THE REPORTED AE DOES MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE DEFINITION OF UADE (UNANTICIPATED ADVERSE DEVICE EVENT).

Description of Event or Problem

AS REPORTED PER CLINICAL TRIAL (B)(4): THE SUBJECT PATIENT UNDERWENT OPEN AND LAPAROSCOPIC COLECTOMY PROCEDURE ON (B)(6) 2024 DURING WHICH A TRIMMED PHASIX MESH WAS PLACED IN AN ONLAY FASHION AND SUTURED USING ABSORBABLE MONOFILAMENT 2.0 PDS SUTURES. A 3 CM OVERLAP IN ALL DIRECTIONS WAS ACHIEVED. THE SUBJECT PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT HAS BEEN DIAGNOSED WITH INCISIONAL ABSCESS REQUIRING DRAINAGE. THE SUBJECT PATIENT WAS READMITTED FOR PERIUMBILICAL ERYTHEMA AND PAIN WITH CT DEMONSTRATING SUBCUTANEOUS FLUID COLLECTION CONCERNING SEROMA THEREFORE IR DRAIN PLACED ON (B)(6) 2024 AND PROVIDED ANTIBIOTICS (IV VANCOMYCIN AND CLINDAMYCIN). PATIENT WAS HOSPITALIZED. THE REPORTED ADVERSE EVENT (INCISIONAL ABSCESS) HAS BEEN ASSESSED PER CLINICIAN AS PROBABLY RELATED TO THE STUDY DEVICE AND CAUSALLY RELATED TO THE PROCEDURE AND RECOVERED/RESOLVED. THE AE HAS BEEN ASSESSED AS MODERATE IN SEVERITY. THE REPORTED AE DOES MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE DEFINITION OF UADE (UNANTICIPATED ADVERSE DEVICE EVENT). ADDENDUM: ON (B)(6) 2024, PATIENT REPORTED CHRONIC POST-OPERATIVE ABDOMINAL PAIN. THE SUBJECT REPORTS LINGERING CHRONIC PAIN IN THE ABDOMINAL REGION NEAR WHERE THE MESH WAS IMPLANTED. THE DISCOMFORT LIMITS PHYSICAL ACTIVITIES SUCH AS YOGA, DANCE, AND STRETCHING. THE SUBJECT OBSERVES NO SKIN CHANGES, NO SIGN OF INFECTION, NOR ANY BULGES/SIGN OF HERNIA OR MESH PROTRUSION. THE STUDY TEAM WILL CONTINUE TO MONITOR PATIENT'S PAIN IN FOLLOW-UP, PATIENT CONSIDERING POSSIBLE MESH EXPLANTATION IF SYMPTOMS DO NOT RESOLVE. THE REPORTED ADVERSE EVENT (ABDOMINAL PAIN) HAS BEEN ASSESSED PER CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE AND CAUSALLY RELATED TO THE PROCEDURE AND NOT RECOVERED/NOT RESOLVED. THE AE HAS BEEN ASSESSED AS MODERATE IN SEVERITY. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE DEFINITION OF UADE (UNANTICIPATED ADVERSE DEVICE EVENT).

Additional Manufacturer Narrative

AS REPORTED, PATIENT DEVELOPED INCISIONAL ABSCESS AND SEROMA POST IMPLANT OF PHASIX MESH. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE COURSE OF INCISIONAL ABSCESS AND SEROMA AS PROBABLY RELATED TO THE STUDY DEVICE WITH CAUSAL RELATIONSHIP TO THE PROCEDURE. HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. SEROMA IS A CLINICALLY UNDERSTOOD POTENTIAL COMPLICATION OF SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE AS A POSSIBLE COMPLICATION. ADDENDUM #1: H11: THIS SUPPLEMENTAL MDR IS SUBMITTED TO UPDATE THE DHR RESULTS AND TO CORRECT THE UDI. REVIEW OF MANUFACTURING RECORDS SHOWS PRODUCT WAS MADE TO SPECIFICATION. ADDENDUM #2: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAD ABDOMINAL PAIN. THE REPORTED ADVERSE EVENT (ABDOMINAL PAIN) HAS BEEN ASSESSED PER CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE AND CASUALLY RELATED TO THE PROCEDURE AND NOT RECOVERED/ NOT RESOLVED. PAIN IS CLINICALLY UNDERSTOOD POTENTIAL COMPLICATION OF SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE AS A POSSIBLE COMPLICATION. REVIEW OF MANUFACTURING RECORDS SHOWS PRODUCT WAS MADE TO SPECIFICATION. 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.