MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PHASIX MESH; SURGICAL MESH

Catalog Number	1192030
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	01/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the subject patient was diagnosed with prolonged ileus post implant of a phasix mesh as an onlay.The clinician has assessed the patient¿s postoperative course as possibly related to the study device and 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 course is unknown.Hence, no conclusions can be made.A review of manufacturing records was conducted and shows the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 122 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.
Event or Problem Description
As reported per clinical trial (b)(4): the subject patient was admitted to the hospital on (b)(6) 2026 and underwent an open relaparotomy colectomy and lysis of adhesion during which a phasix flat mesh onlay was placed and secured in place with absorbable multifilament sutures with 2-0 pds.The surgery was done with trimming the phasix mesh.On (b)(6) 2026, the subject patient developed prolonged ileus.Patient received a picc line to initiate total parenteral nutrition.On (b)(6) 2026, the patient was discharged from hospital.The reported adverse event (prolonged ileus) has been assessed per clinicians as possibly related to the study device and to the procedure.It has been assessed as moderate in severity; the reported ae meets the definition of a sae (serious adverse event) and does not meet the definition of usade (unanticipated serious adverse device event).
Event or Problem Description
As reported per clinical trial (b)(4): the subject patient was admitted to the hospital on (b)(6) 2026 and underwent an open relaparotomy colectomy and lysis of adhesion during which a phasix flat mesh onlay was placed and secured in place with absorbable multifilament sutures with 2-0 pds.The surgery was done with trimming the phasix mesh.On (b)(6) 2026, the subject patient developed prolonged ileus.Patient received a picc line to initiate total parenteral nutrition.On (b)(6) 2026, the patient was discharged from hospital.The reported adverse event (prolonged ileus) has been assessed per clinicians as possibly related to the study device and to the procedure.It has been assessed as moderate in severity; the reported ae meets the definition of a sae (serious adverse event) and does not meet the definition of usade (unanticipated serious adverse device event).Addendum: event term correct to "postoperative" ileus.The date event was updated to (b)(6) 2026.The reported adverse event (postoperative ileus) has been assessed per clinicians as possibly related to the study device and to the procedure and the adverse event was recovered/resolved on (b)(6) 2026.It has been assessed as severe in severity.
Additional Manufacturer Narrative
As reported, the subject patient was diagnosed with prolonged ileus post implant of a phasix mesh as an onlay.The clinician has assessed the patient¿s postoperative course as possibly related to the study device and 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 course is unknown.Hence, no conclusions can be made.A review of manufacturing records was conducted and shows the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.Addendum: h11: this is an addendum to the initial mdr submitted to document additional/corrected information.As reported, the subject patient was diagnosed with postoperative ileus post implant of a phasix mesh as an onlay.This condition has resolved.No conclusions can be made; the extent to which the phasix mesh implant used to treat the patient may have caused or contributed to the reported patient's postoperative course is unknown.Updated fields: b4, b7, g3, g6, h2, h4, h6, h10, h11.Corrected fields: b3 (date of event), b5.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: 24245675
• Report Number: 1213643-2026-00070
• Device Sequence Number: 8402779
• Product Code: OOD
• UDI-Device Identifier: 00801741107627
• UDI-Public: (01)00801741107627(11)250127(17)261028(10)HUKN1456
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Followup
• Report Date (Section B): 02/05/2026

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: 1192030
• Device Lot Number: HUKN1456
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 02/10/2026
• 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: Hospitalization; Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 107 KG