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

Catalog Number	1162020
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Erosion (1750); Fistula (1862); Unspecified Infection (1930); Pain (1994); Obstruction/Occlusion (2422)
Date of Event	08/31/2026
Type of Reportable Event	Death
Event or Problem Description
Per information provided: (b)(6)2005 - patient was diagnosed with ventral hernia thereby underwent open repair with implant of composix kugel patch (device 1).Per operative notes, "an incision was made into the midline of the umbilicus.The hernia sac was dissected out.A large composix kugel patch (device 1) was placed into the preperitoneal cavity and secured it with sutures." (b)(6)2013 - patient was diagnosed with adhesion, thereby underwent open repair with explant of composix kugel patch (device 1) and primary hernia repair.Per operative notes, "a midline incision was made into the abdomen.The old mesh (device 1) was removed from abdominal wall.Multiple adhesions to the anterior abdominal wall were carefully lysed from both sides of the anterior abdominal wall.The defect was closed with sutures primarily." (b)(6)2014 - patient was diagnosed with abdominal wall infection, ventral hernia, necrosis, abscess, purulent discharge thereby underwent open repair with implant of xenmatrix graft (device 2).Per operative notes, "an incision was made around the previous infected skin.There were necrotic tissues present into the abdominal cavity.The hernia sac was dissected out.Into the abdominal cavity some purulent fluid and abscess was present.All fluids and abscess cavities were taken down sharply.A xenmatrix graft (device 2) was placed into the peritoneal cavity and secured it withs sutures." attorney alleges that patients had adhesion, obstruction, fistula, infection, pain, mesh erosion and "enterocutaneous fistula for years after implant and which ultimately was a factor in death.".
Additional Manufacturer Narrative
Based on the information received, post implant of composix kugel patch (device #1), patient had adhesion, thereby underwent removal of mesh and implant of xenmatrix graft (device #2).Per plaintiff profile form, patient had adhesions, obstruction, fistula, infection, pain, mesh erosion and "enterocutaneous fistula for years after implant and which ultimately was a factor in death." no information regarding patient's death in the medical records provided to date and no autopsy report, or death certificate have been provided.Note, the actual date of death is unknown.We have documented this required date field with a best estimate.Note, the date of event (31-aug-2026) is estimated based on the date of awareness.This emdr represents the xenmatrix graft (device 2).An additional supplemental emdr was submitted to represent the composix kugel patch (device 1).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: XenMatrix
• Common Device Name: Porcine 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: 50798277
• Report Number: 1213643-2026-01204
• Device Sequence Number: 18794297
• Product Code: FTM
• UDI-Device Identifier: 00801741031458
• UDI-Public: (01)00801741031458
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/07/2026

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 Catalogue Number: 1162020
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Death
• Patient Sex: Female