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	03/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the subject patient was diagnosed with a seroma post implant of phasix flat mesh.The seroma resolved without intervention.The clinician has assessed the patient's postoperative seroma as possibly related to the study device and probable relationship to the procedure.However, based on the information provided, the extent to which the phasix flat mesh implant used to treat the patient may have caused or contributed to the reported patient's postoperative seroma cannot be determined.Hence, 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 manufacturing records was performed and found that the device was manufactured to specification.To date, this is the only reported complaint for this lot of (b)(4) units released for distribution.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)(6): the subject patient was admitted to the hospital on (b)(6) 2026 and underwent an open primary laparotomy, colectomy, exploratory laparotomy and small bowel resection during which a phasix flat mesh onlay was placed and secured in place with absorbable monofilament sutures with 2-0 pds.The surgery was done with trimming the phasix mesh (39 cm length and 6 cm width).The midline fascia was completely closed with ethicon slow absorbing monofilament with running stitches approximately 1 cm far apart and 30 cm in length.Patient was discharged from hospital on (b)(6) 2026.On (b)(6) 2026, the subject patient developed a small seroma on incision site, no treatment or test done.The seroma was resolved on (b)(6) 2026.The reported adverse event (seroma) has been assessed per clinicians as possible related to the study device and a probable relationship to the procedure.It has been assessed as mild in severity and recovered and resolved; 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: 24839738
• Report Number: 1213643-2026-00472
• Device Sequence Number: 17630306
• Product Code: OOD
• UDI-Device Identifier: 00801741107634
• UDI-Public: (01)00801741107634(11)250127(17)261028(10)HUKN1458
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K161424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

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 Catalogue Number: 1192040
• Device Lot Number: HUKN1458
• 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: 03/26/2026
• Initial Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2025
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 80 KG