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	Seroma (2069)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported per clinical trial dvl-he-018: the subject patient underwent laparoscopic primary colectomy and exploratory laparotomy on (b)(6) 2025 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) 2025.On (b)(6) 2025, patient with bulge identified at post-op visit with np.Seroma was diagnosed via ct scan.The reported adverse event (seroma) has been assessed per clinicians as causally related to the study device and to the procedure.It has been assessed as moderate in severity, and it has recovered/resolved on (b)(6) 2025.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 seroma post implant of a phasix mesh.The clinician has assessed the patient¿s postoperative outcome as causally related to the study device and causally related to the procedure.However, based on the information provided, no conclusions can be made.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.A review of the manufacturing records was performed and found the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.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.

• 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: 22393653
• Report Number: 1213643-2025-00555
• Device Sequence Number: 9017491
• Product Code: OOD
• UDI-Device Identifier: 00801741107634
• UDI-Public: (01)00801741107634(11)230621(17)250528(10)HUHT1389
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K161424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2025

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: 05/28/2025
• Device Catalogue Number: 1192040
• Device Lot Number: HUHT1389
• 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: 06/13/2025
• Initial Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2023
• 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
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 83 KG