MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PHASIX MESH; SURGICAL MESH

Catalog Number	1191025
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abscess (1690); Bacterial Infection (1735); Unspecified Infection (1930); Hernia (2240)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported per the clinical trial dvl-he-018: the subject patient underwent a laparoscopic primary laparotomy mesenteric lymph node incision at umbilicus with concomitant procedures oophorectomy, small bowel resection and liver biopsy on (b)(6) 2024, during which a phasix mesh was trimmed, placed in onlay fashion, and secured in place with absorbable monofilament 3-0 pds sutures.A 3 cm overlap in all directions was achieved.The midline fascia was completely closed with slow absorbable monofilament 1 pds sutures.Skin closure was achieved by using sutures and surgical glue.On (b)(6) 2024, patient was diagnosed with infection, abscess and underwent surgery to remove fluid collection above the phasix mesh.The phasix mesh was intact and the incision from the surgery is partially closed to leave one area open for packing.The patient was discharged from hospital on (b)(6) 2024.The reported adverse event (infection, fluid collection/abscess) has been assessed per clinician as possibly related to the study device, possibly related to procedure, and recovered/resolved.The ae has been assessed as severe in severity.The reported ae does meet the definition of a sae (serious adverse event) and does not meet the definition of a uade (unanticipated adverse device event).
Additional Manufacturer Narrative
As reported, after undergoing a procedure which included the implant of a phasix mesh, laparoscopic primary laparotomy mesenteric lymph node incision at umbilicus with concomitant procedures oophorectomy, small bowel resection and liver biopsy the patient was diagnosed with infection and abscess.The clinician has assessed the patient¿s postoperative outcome as possibly related to the study device and to the procedure.However, based on the information provided, no conclusion can be made as to the degree to which the phasix mesh may have caused or contributed the patient¿s postoperative course.Infection is a known inherent risk of surgery and is listed as a possible complication in the adverse reaction section of the instructions-for-use supplied with the device.Regarding infection, the warnings section states, ¿ if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the mesh.¿ review of manufacturing records shows product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in september 2022.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.H3 other text : not returned.
Additional Manufacturer Narrative
As reported, after undergoing a procedure which included the implant of a phasix mesh, laparoscopic primary laparotomy mesenteric lymph node incision at umbilicus with concomitant procedures oophorectomy, small bowel resection and liver biopsy the patient was diagnosed with infection and abscess.The clinician has assessed the patient¿s postoperative outcome as possibly related to the study device and to the procedure.However, based on the information provided, no conclusion can be made as to the degree to which the phasix mesh may have caused or contributed the patient¿s postoperative course.Infection is a known inherent risk of surgery and is listed as a possible complication in the adverse reaction section of the instructions-for-use supplied with the device.Regarding infection, the warnings section states, ¿ if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the mesh.¿ review of manufacturing records shows product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in september 2022.Addendum: this is an addendum to the initial mdr submitted to document additional/corrected information provided.Based on the additional information received, no conclusions can be made.The corrected and additional information received finds the intraoperative incision and drainage (i&d) was performed on (b)(6) 2024 and cultures taken were positive for bacterial infection.Updated fields: b4, b5, b6, b7, g3, g6, h2, h6, h10 corrected field: b5 (dates of procedure and discharge) 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.H3 other text : not returned.
Event or Problem Description
As reported per the clinical trial (b)(4) : the subject patient underwent a laparoscopic primary laparotomy mesenteric lymph node incision at umbilicus with concomitant procedures oophorectomy, small bowel resection and liver biopsy on (b)(6) 2024, during which a phasix mesh was trimmed, placed in onlay fashion, and secured in place with absorbable monofilament 3-0 pds sutures.A 3 cm overlap in all directions was achieved.The midline fascia was completely closed with slow absorbable monofilament 1 pds sutures.Skin closure was achieved by using sutures and surgical glue.On (b)(6) 2024, patient was diagnosed with infection, abscess and underwent surgery to remove fluid collection above the phasix mesh.The phasix mesh was intact and the incision from the surgery is partially closed to leave one area open for packing.The patient was discharged from hospital on (b)(6) 2024.The reported adverse event (infection, fluid collection/abscess) has been assessed per clinician as possibly related to the study device, possibly related to procedure, and recovered/resolved.The ae has been assessed as severe in severity.The reported ae does meet the definition of a sae (serious adverse event) and does not meet the definition of a uade (unanticipated adverse device event).Addendum per additional/corrected information received: intraoperative incision and drainage (i&d) was performed on (b)(6) 2024.Cultures taken from i&d procedure were positive for few enterocloster clostridioformis and parabacteroides merdae.Patient was discharged on (b)(6) 2024.
Additional Manufacturer Narrative
As reported, after undergoing a procedure which included the implant of a phasix mesh, laparoscopic primary laparotomy mesenteric lymph node incision at umbilicus with concomitant procedures oophorectomy, small bowel resection and liver biopsy the patient was diagnosed with infection and abscess.The clinician has assessed the patient¿s postoperative outcome as possibly related to the study device and to the procedure.However, based on the information provided, no conclusion can be made as to the degree to which the phasix mesh may have caused or contributed the patient¿s postoperative course.Infection is a known inherent risk of surgery and is listed as a possible complication in the adverse reaction section of the instructions-for-use supplied with the device.Regarding infection, the warnings section states, ¿ if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the mesh.¿ review of manufacturing records shows product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 23 units released for distribution in september 2022.Addendum #1: this is an addendum to the initial mdr submitted to document additional/corrected information provided.Based on the additional information received, no conclusions can be made.The corrected and additional information received finds the intraoperative incision and drainage (i&d) was performed on (b)(6) 2024 and cultures taken were positive for bacterial infection.Addendum #2: this is an addendum to the initial mdr submitted to document additional information provided.Based on the additional information received, patient had hernia recurrence, and the mesh was completely explanted.The reported adverse event (hernia recurrence) has been assessed per clinician as possibly related to the study device and casually related to the procedure and recovered/resolved.Hernia recurrence is a known inherent risk of surgery and is listed as a possible complication in the adverse reaction section of the instructions-for-use supplied with the device.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.
Event or Problem Description
As reported per the clinical trial (b)(4): the subject patient underwent a laparoscopic primary laparotomy mesenteric lymph node incision at umbilicus with concomitant procedures oophorectomy, small bowel resection and liver biopsy on (b)(6) 2024, during which a phasix mesh was trimmed, placed in onlay fashion, and secured in place with absorbable monofilament 3-0 pds sutures.A 3 cm overlap in all directions was achieved.The midline fascia was completely closed with slow absorbable monofilament 1 pds sutures.Skin closure was achieved by using sutures and surgical glue.On (b)(6) 2024, patient was diagnosed with infection, abscess and underwent surgery to remove fluid collection above the phasix mesh.The phasix mesh was intact and the incision from the surgery is partially closed to leave one area open for packing.The patient was discharged from hospital on (b)(6) 2024.The reported adverse event (infection, fluid collection/abscess) has been assessed per clinician as possibly related to the study device, possibly related to procedure, and recovered/resolved.The ae has been assessed as severe in severity.The reported ae does meet the definition of a sae (serious adverse event) and does not meet the definition of a uade (unanticipated adverse device event).Addendum per additional/corrected information received: intraoperative incision and drainage (i&d) was performed on (b)(6) 2024.Cultures taken from i&d procedure were positive for few enterocloster clostridioformis and parabacteroides merdae.Patient was discharged on (b)(6) 2024.Addendum per additional information received: on (b)(6) 2025, patient had hernia recurrence, and the mesh was completely explanted.The reported adverse event (hernia recurrence) has been assessed per clinician as possibly related to the study device and casually related to the procedure and recovered/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 the definition of a uade (unanticipated adverse device event).

• Brand Name: PHASIX MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 18788876
• Report Number: 1213643-2024-00060
• Device Sequence Number: 15412012
• Product Code: OOD
• UDI-Device Identifier: 00801741107580
• UDI-Public: (01)00801741107580(17)240528(10)HUGT1606
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K161424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2024
• Device Catalogue Number: 1191025
• Device Lot Number: HUGT1606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: 02/29/2024; 03/24/2025
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 03/13/2024; 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 64 KG