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 Code	Seroma (2069)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the subject patient developed a seroma post implant of a phasix mesh.The clinician has assessed the patient¿s postoperative outcome as possibly related to the study device and possibly 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.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 dvl-he-018: the subject patient was admitted to hospital on (b)(6) 2025 and patient underwent an open primary exploratory laparotomy and small bowel resection during which a phasix mesh was placed and secured in place with absorbatack.The surgery was done with trimming the phasix mesh and the midline fascia was completely closed with ethicon slow absorbable monofilament 0 pds sutures and at least 3 cm and no greater than 4 cm overlap in all directions (superior, inferior, and laterally) beyond the margins of the fascial incision.Patient was discharged from hospital on (b)(6) 2025.On (b)(6) 2025, patient was diagnosed with seroma on ctap scan and drain placed on (b)(6) 2025.The reported adverse event (seroma) has been assessed per clinicians as possibly related to the study device and to the procedure.It has been assessed as moderate in severity, and it is recovering/resolving.The reported ae does not meet the definition of a sae (serious adverse event) and the definition of usade (unanticipated serious 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: 22144544
• Report Number: 1213643-2025-00431
• Device Sequence Number: 20704750
• Product Code: OOD
• UDI-Device Identifier: 00801741107610
• UDI-Public: (01)00801741107610(11)230621(17)250528(10)HUHT1373
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/19/2025

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: 1191530
• Device Lot Number: HUHT1373
• 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: 05/15/2025
• Initial Report FDA Received Date: 06/04/2025
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 57 KG