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

Catalog Number	1191530
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Unspecified Infection (1930); Seroma (2069)
Date of Event	01/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported per clinical trial (b)(6): on (b)(6) 2024, the subject patient underwent an exploratory primary laparotomy, low anterior and small bowel resection, partial hepatectomy, omental pedicle flab secured in pelvis with concomitant partial colectomy, appendectomy, hysterectomy and oophorectomy, during which a bard/davol phasix mesh was trimmed, placed in onlay fashion and secured with absorbable monofilament 3.0 pds sutures.A 3cm overlap in all directions was achieved.The midline fascia was completely closed with slow absorbable monofilament 0 pds sutures.Skin closure was achieved using staples.On (b)(6) 2024, the subject patient was diagnosed with surgical site infection and required medication.Patient had 1 staple removed and midline probed in inferior area with small amount of pus- packed with gauze.A ct scan of abdomen and pelvis on showed no abdominal or pelvis abscess.Keflex was switched to cefazolin iv.On (b)(6) 2024, the subject patient was seen in clinic and the lower part of the incision still appeared erythematous.Augmentin was prescribed to treat possible superficial infection.Patient is scheduled to be seen again on (b)(6) 2024.The reported adverse event (surgical site infection) has been assessed per clinician as possibly related to the study device, possibly related to the procedure and not recovering/resolving.The ae has been assessed as mild 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, the patient was diagnosed with a surgical site infection post implant of phasix mesh.The clinician has assessed the patient¿s postoperative course of surgical site infection as possibly related to the study device and procedure.However, based on the information provided, no conclusion can be made as to the degree to which the implant may have caused or contributed to the patient¿s postoperative infection.Review of manufacturing records shows the 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 january 2023.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.Additionally, the warning 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." 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 clinical trial (b)(4): on (b)(6) 2024, the subject patient underwent an exploratory primary laparotomy, low anterior and small bowel resection, partial hepatectomy, omental pedicle flab secured in pelvis with concomitant partial colectomy, appendectomy, hysterectomy and oophorectomy, during which a bard/davol phasix mesh was trimmed, placed in onlay fashion and secured with absorbable monofilament 3.0 pds sutures.A 3cm overlap in all directions was achieved.The midline fascia was completely closed with slow absorbable monofilament 0 pds sutures.Skin closure was achieved using staples.On (b)(6) 2024, the subject patient was diagnosed with surgical site infection and required medication.Patient had 1 staple removed and midline probed in inferior area with small amount of pus- packed with gauze.A ct scan of abdomen and pelvis on showed no abdominal or pelvis abscess.Keflex was switched to cefazolin iv.On (b)(6) 2024, the subject patient was seen in clinic and the lower part of the incision still appeared erythematous.Augmentin was prescribed to treat possible superficial infection.Patient is scheduled to be seen again on (b)(6) 2024.The reported adverse event (surgical site infection) has been assessed per clinician as possibly related to the study device, possibly related to the procedure and not recovering/resolving.The ae has been assessed as mild 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 information received: the reported adverse event (surgical site infection) has been assessed per clinician as recovered/resolved.
Additional Manufacturer Narrative
As reported, the patient was diagnosed with a surgical site infection post implant of phasix mesh.The clinician has assessed the patient¿s postoperative course of surgical site infection as possibly related to the study device and procedure.However, based on the information provided, no conclusion can be made as to the degree to which the implant may have caused or contributed to the patient¿s postoperative infection.Review of manufacturing records shows the 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 january 2023.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.Additionally, the warning 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." addendum: this is an addendum to the initial mdr submitted to document that the ae has been recovered/resolved.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, the patient was diagnosed with a surgical site infection post implant of phasix mesh.The clinician has assessed the patient¿s postoperative course of surgical site infection as possibly related to the study device and procedure.However, based on the information provided, no conclusion can be made as to the degree to which the implant may have caused or contributed to the patient¿s postoperative infection.Review of manufacturing records shows the 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 january 2023.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.Additionally, the warning 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." addendum 1: this is an addendum to the initial mdr submitted to document that the ae has been recovered/resolved.Addendum 2: this is an addendum to the initial mdr submitted to document that the additional information received.As reported, the patient developed a seroma three (3) months following implantation of the phasix mesh, which was diagnosed via pet scan.The clinician has assessed the patient's postoperative seroma formation as possibly related to the study device and probably related to the procedure.However, based on the information provided, no conclusion can be made as to the degree to which the implant may have caused or contributed to the patient¿s postoperative seroma.Seroma formation is a clinically understood potential complication of surgery/use of the device and is identified in the instructions-for-use provided 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.
Event or Problem Description
As reported per clinical trial (b)(4): on (b)(6) 2024, the subject patient underwent an exploratory primary laparotomy, low anterior and small bowel resection, partial hepatectomy, omental pedicle flab secured in pelvis with concomitant partial colectomy, appendectomy, hysterectomy and oophorectomy, during which a bard/davol phasix mesh was trimmed, placed in onlay fashion and secured with absorbable monofilament 3.0 pds sutures.A 3cm overlap in all directions was achieved.The midline fascia was completely closed with slow absorbable monofilament 0 pds sutures.Skin closure was achieved using staples.On (b)(6) 2024, the subject patient was diagnosed with surgical site infection and required medication.Patient had 1 staple removed and midline probed in inferior area with small amount of pus- packed with gauze.A ct scan of abdomen and pelvis on showed no abdominal or pelvis abscess.Keflex was switched to cefazolin iv.On (b)(6) 2024, the subject patient was seen in clinic and the lower part of the incision still appeared erythematous.Augmenting was prescribed to treat possible superficial infection.Patient is scheduled to be seen again on (b)(6) 2024.The reported adverse event (surgical site infection) has been assessed per clinician as possibly related to the study device, possibly related to the procedure and not recovering/resolving.The ae has been assessed as mild 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 information received: the reported adverse event (surgical site infection) has been assessed per clinician as recovered/resolved.Addendum per additional information received: on (b)(6) 2024, ct scan was done stating "somewhat worsening inflammatory changes along midline incision with no drainable fluid component.On (b)(6) 2024, the patient was diagnosed with an asymptomatic abdominal seroma.Upon imv, a pet scan was noted to have a 7.2 x 5.5 x 8.7 cm fluid collection/seroma conservative management for this.Interval ct scans on (b)(6) 2024, (b)(6) 2025 and (b)(6) 2026 notes mild interval decrease in fluid collection size from previous imaging.The reported adverse event (seroma) has been assessed per clinician as possibly related to the study device, and probably related to the procedure.The ae has been assessed as mild in severity and recovering/resolving.The reported ae does not meet the definition of a sae (serious adverse 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: 18621747
• Report Number: 1213643-2024-00023
• Device Sequence Number: 2405917
• Product Code: OOD
• UDI-Device Identifier: 00801741107610
• UDI-Public: (01)00801741107610(17)240928(10)HUGX1690
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K161424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/12/2026

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: 09/28/2024
• Device Catalogue Number: 1191530
• Device Lot Number: HUGX1690
• 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: 01/12/2024
• Supplement Date Received by Manufacturer: 02/14/2024; 05/11/2026
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 02/21/2024; 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2023
• 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; Other
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 139 KG