PHASIX MESH

Description of Event or Problem

AS REPORTED PER CLINICAL TRIAL (B)(4): THE SUBJECT PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2023 AND UNDERWENT OPEN MIDLINE PRIMARY LAPAROTOMY FOR A COLECTOMY WITH CONCOMITANT PROCEDURE OF OSTOMY ON (B)(6) 2023 DURING WHICH A PHASIX MESH WAS TRIMMED, PLACED IN AN ONLAY FASHION AND SECURED USING ABSORBABLE MULTIFILAMENT SUTURES. A 3 CM OVERLAP IN ALL DIRECTIONS WAS ACHIEVED. PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2023. THE PATIENT HAD BEEN COUGHING A LOT AND ON (B)(6) 2025 A PROTRUSION APPEARED IN THE UPPER QUARTER OF THE LAPAROTOMY SCAR. SONOGRAPHY SHOWED AN INCISIONAL HERNIA WITH 5 CM DIAMETER. ON (B)(6) 2025 THE PATIENT HAD NO COMPLAINTS REGARDING THE HERNIA. THE SIZE OF THE HERNIA IS THE SAME AS DOCUMENTED IN (B)(6) 2025. THE SUBJECT PATIENT DOES NOT WANT ANY ACTION TAKEN. THE REPORTED ADVERSE EVENT (INCISIONAL HERNIA) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND A CAUSAL RELATIONSHIP TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MILD IN SEVERITY. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND THE DEFINITION OF UADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).

Additional Manufacturer Narrative

AS REPORTED, THE SUBJECT PATIENT DEVELOPED AN INCISIONAL HERNIA AT THE SITE OF THE PHASIX MESH ONLAY AFTER COUGHING. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE OUTCOME AS POSSIBLY RELATED TO THE STUDY DEVICE AND CAUSALLY RELATED TO THE PROCEDURE. HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. HERNIA RECURRENCE IS LISTED AS A POSSIBLE COMPLICATION IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE, PROVIDED WITH THE DEVICE. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THE LOT WAS MANUFACTURED 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.

Additional Manufacturer Narrative

AS REPORTED, THE SUBJECT PATIENT DEVELOPED AN INCISIONAL HERNIA AT THE SITE OF THE PHASIX MESH ONLAY AFTER COUGHING. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE OUTCOME AS POSSIBLY RELATED TO THE STUDY DEVICE AND CAUSALLY RELATED TO THE PROCEDURE. HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. HERNIA RECURRENCE IS LISTED AS A POSSIBLE COMPLICATION IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE, PROVIDED WITH THE DEVICE. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THE LOT WAS MANUFACTURED TO SPECIFICATION. ADDENDUM: H11: THIS IS AN ADDENDUM TO THE INITIAL MDR SUBMITTED. THIS MDR (REF. NO. 1213643-2025-00688) WAS SUBMITTED IN ERROR, AS THIS IS A DUPLICATE OF A PREVIOUSLY SUBMITTED MDR, (REF. NO. 1213643-2025-00359), AND THE COMPLAINT SHALL BE VOIDED. UPDATED FIELDS: B4, G3, G6, H2, H10, H11. 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 DVL-HE-018: THE SUBJECT PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2023 AND UNDERWENT OPEN MIDLINE PRIMARY LAPAROTOMY FOR A COLECTOMY WITH CONCOMITANT PROCEDURE OF OSTOMY ON (B)(6) 2023 DURING WHICH A PHASIX MESH WAS TRIMMED, PLACED IN AN ONLAY FASHION AND SECURED USING ABSORBABLE MULTIFILAMENT SUTURES. A 3 CM OVERLAP IN ALL DIRECTIONS WAS ACHIEVED. PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2023. THE PATIENT HAD BEEN COUGHING A LOT AND ON (B)(6) 2025 A PROTRUSION APPEARED IN THE UPPER QUARTER OF THE LAPAROTOMY SCAR. SONOGRAPHY SHOWED AN INCISIONAL HERNIA WITH 5 CM DIAMETER. ON (B)(6) 2025 THE PATIENT HAD NO COMPLAINTS REGARDING THE HERNIA. THE SIZE OF THE HERNIA IS THE SAME AS DOCUMENTED IN (B)(6) 2025. THE SUBJECT PATIENT DOES NOT WANT ANY ACTION TAKEN. THE REPORTED ADVERSE EVENT (INCISIONAL HERNIA) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND A CAUSAL RELATIONSHIP TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MILD IN SEVERITY. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND THE DEFINITION OF UADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).