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	Hernia (2240)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient was diagnosed with a hernia post implant of the phasix mesh.The clinician has assessed the patient¿s postoperative course of hernia as possibly related to the study device and causally related to the procedure and not recovered/ not resolved.However, based on the information provided the degree to which the phasix mesh used to treat the patient, may have caused, or contributed to the patient's postoperative course is unknown.Review of the manufacturing records shows the product was manufactured to specification.This mdr is submitted to document the hernia occurrence on (b)(6) 2025.Mdr 1213643-2024-00017 was previously submitted to document the postoperative surgical site infection.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): 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.(note the ssi resolved on 01-feb-2024 and was reported to the fda reference (b)(4).On (b)(6) 2025, the subject patient was diagnosed with a hernia occurrence through ct scan.As reported, the adverse event (hernia) has been assessed per clinician as possibly related to the study device with a causal relationship to the procedure and not recovered/ not resolved.The severity has been assessed as mild.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).

• 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: 24376757
• Report Number: 1213643-2026-00160
• Device Sequence Number: 5676086
• Product Code: OOD
• UDI-Device Identifier: 00801741107634
• UDI-Public: (01)00801741107634(17)231128(10)HUFZ1071
• 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
• Report Date (Section B): 02/02/2026

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: 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: 01/28/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 161 KG