MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 PHASIX; Surgical Mesh

Catalog Number	1193045
Medical Device Problem Codes	Patient-Device Incompatibility (2682); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hernia (2240); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported per clinical trial (b)(4): the subject patient underwent an open primary exploratory laparotomy with distal pancreatectomy, splenectomy splenic artery lymphadenectomy, omental flap, liver wedge biopsy as concomitant procedures on (b)(6) 2025, during which the patient was implanted with phasix mesh onlay was trimmed and implanted using 3-0 pds absorbable monofilament suture.The midline fascia was completely closed with slow absorbing monofilament 0 pds sutures using running stitch.Subject was known to have pancreatic leak from pod 3 drain amylase (1781), sent home with jps to remove later.The subject was discharged from hospital on (b)(6) 2025.(b)(6) 2026 - the patient was diagnosed with an incisional hernia occurrence.During the 12-month follow-up visit, the sub-i palpated a 5 x 5 cm hernia on physical examination.As reported, the adverse event (incisional hernia occurrence) has been assessed per clinician (medical monitor) as probably related to the study device, causally related to the procedure and not recovered/not resolved.The ae has been assessed as mild in severity.The reported ae does not meet the definition of a sae (serious adverse event) and does not meet the definition of usade (unanticipated serious adverse device event).
Additional Manufacturer Narrative
As reported, the subject patient was diagnosed with incisional hernia occurrence post implant of phasix mesh as an onlay.The clinician (medical monitor) has assessed the ae as probably related to the study device, causally related to the procedure.However, based on the information provided, the extent to which the phasix mesh implant used to treat the patient may have caused or contributed to the reported patient's postoperative condition cannot be determined.Hence, no conclusions can be made.A review of manufacturing records was performed and found that the device was manufactured to specification.The warning section of the instructions-for-use supplied with the device states, "to prevent recurrences when repairing hernias or to prevent occurrences when reinforcing surgical incisions prophylactically, the mesh should be sized with appropriate overlap for the size and location of the defect or surgical incision, taking into consideration any additional clinical factors applicable to the patient.Careful attention to mesh fixation placement and spacing will help prevent excessive tension or gap formation between the mesh and fascial tissue" note mdr 1213643-2025-00326 was previously submitted for this same subject patient (b)(6) to document information associated with an unrelated ae.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
• 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 ; +1(800)556-6756
• MDR Report Key: 50103761
• Report Number: 1213643-2026-00995
• Device Sequence Number: 10032953
• Product Code: OOD
• UDI-Device Identifier: 00801741107672
• UDI-Public: (01)00801741107672(11)230628(17)250528(10)HUHT1764
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2026

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: 05/28/2025
• Device Catalogue Number: 1193045
• Device Lot Number: HUHT1764
• 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: 07/17/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 08/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2023
• 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: Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 244 LB