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

Catalog Number	1192040
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient was diagnosed with a surgical site infection post implant of the phasix mesh.The clinician has assessed the patient¿s postoperative course of surgical site infection as possibly related to the study device, and definitely related to the procedure.However, based on the information provided, no conclusion can be made.Review of the manufacturing records shows the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(6) released for distribution in (b)(6) 2022.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 the clinical trial dvl-he-018: the subject patient underwent an open exploratory primary laparotomy with concomitant procedures hysterectomy, oophorectomy, left salpingectomy and right salpingo-oophorectomy on (b)(6) 2023, during which a bard/davol phasix mesh was trimmed, placed in onlay fashion and secured in place.The midline fascia was completely closed with slow absorbing monofilament 1 pds sutures.A 3cm overlap in all directions was achieved.Skin closure was achieved by running stitch with long term absorbable sutures.The subject patient was discharged from the hospital on (b)(6) 2023.On (b)(6) 2023, the subject patient was diagnosed with superficial surgical site infection and required medication.The reported adverse event (surgical site infection) has been assessed per clinician as possibly related to the study device, definitely related to the procedure and recovering/resolving.The ae has been assessed as mild in severity.The reported ae does not meet the definition of a sae (serious adverse event) and uade (unanticipated adverse device event).
Event or Problem Description
As reported per the clinical trial (b)(6): the subject patient underwent an open exploratory primary laparotomy with concomitant procedures hysterectomy, oophorectomy, left salpingectomy and right salpingo-oophorectomy on (b)(6) 2023, during which a bard/davol phasix mesh was trimmed, placed in onlay fashion and secured in place.The midline fascia was completely closed with slow absorbing monofilament 1 pds sutures.A 3cm overlap in all directions was achieved.Skin closure was achieved by running stitch with long term absorbable sutures.The subject patient was discharged from the hospital on (b)(6) 2023.On (b)(6) 2023, the subject patient was diagnosed with superficial surgical site infection and required medication.The reported adverse event (surgical site infection) has been assessed per clinician as possibly related to the study device, definitely related to the procedure and recovering/resolving.The ae has been assessed as mild in severity.The reported ae does not meet the definition of a sae (serious adverse event) and uade (unanticipated adverse device event).Addendum per additional information received: the subject patient was diagnosed with superficial surgical site infection on (b)(6) 2023 (date correction) and the outcome was recovered/resolved on (b)(6) 2024.
Additional Manufacturer Narrative
As reported, the patient was diagnosed with a surgical site infection post implant of the phasix mesh.The clinician has assessed the patient¿s postoperative course of surgical site infection as possibly related to the study device, and definitely related to the procedure.However, based on the information provided, no conclusion can be made.Review of the manufacturing records shows the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 15 units released for distribution in may 2022.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: h11: 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.

• 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: 18612599
• Report Number: 1213643-2024-00017
• Device Sequence Number: 7444837
• Product Code: OOD
• UDI-Device Identifier: 00801741107634
• UDI-Public: (01)00801741107634
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K161424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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: 11/28/2023
• Device Catalogue Number: 1192040
• Device Lot Number: HUFZ1071
• 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: 01/08/2024
• Supplement Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2022
• 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: 40 YR
• Patient Sex: Female
• Patient Weight: 161 KG