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

Catalog Number	1200710
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Scar Tissue (2060); Hernia (2240)
Date of Event	09/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2018- patient was diagnosed with left incarcerated inguinal hernia thereby underwent laparoscopic repair with implant of 3dmax mesh (device 1).Per op notes, "in right inguinal region, no hernia was noted.In left inguinal region, hernia was identified and dissected.A 3dmax mesh (device 1) was placed covering the hernia defect into the preperitoneal space and was sutured." (b)(6) 2019- patient was diagnosed with incisional hernia, thereby underwent open repair with implant of ventrio st mesh (device 2).Per op notes, "through upper midline epigastric incision, hernia defect was identified and was dissected.An extra-large ventrio st mesh (device 2) was inserted into preperitoneal space and sutured." (b)(6) 2019- patient was diagnosed with infected mesh, incisional hernia, thereby underwent open repair with explant of ventrio st mesh (device 2), implant of phasix st mesh (device 3).Per op notes, "hernia developed seroma and penetrated the ventrio st mesh (device 2) and this mesh was excised.A phasix st mesh (device 3) was placed in the preperitoneal space and was sutured." (b)(6) 2019- patient was diagnosed with recurrent incisional hernia, thereby underwent open repair with implant of ventralex st mesh (device 4).Per op notes, "through previous incision in epigastric region, omental adhesions and scarring were identified around the defect.The fascial defect was identified and was repaired by placing large ventralex st mesh (device 4) was placed in preperitoneal space and sutured.".
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-oct-2018) is considered to be a best estimate.This emdr represents the phasix st mesh (device 3).Additional supplemental emdrs were submitted to represent the 3dmax mesh (device 1) and ventrio st mesh (device 2).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 ST 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 ; +1(800)556-6756
• MDR Report Key: 50091023
• Report Number: 1213643-2026-00989
• Device Sequence Number: 21452305
• Product Code: OWT
• UDI-Device Identifier: 00801741095337
• UDI-Public: (01)00801741095337(17)201028(10)HUCX1924
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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 Expiration Date: 10/28/2020
• Device Catalogue Number: 1200710
• Device Lot Number: HUCX1924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2018
• 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 Sex: Male