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

Catalog Number	1161015
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fistula (1862)
Date of Event	07/07/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2006 ¿ patient was diagnosed with umbilical hernia thereby underwent repair with implant of ventralex mesh (device 1).(note: there is no operative notes for this procedure provided in medical record) on (b)(6) 2006 ¿ per hospital course, patient had status post repair of an incarcerated umbilical hernia, which has been causing bowel obstruction.On (b)(6) 2013 ¿ patient was diagnosed with foreign body, umbilical hernia wound thereby underwent open repair with removal of ventralex mesh (device 1).Per operative notes, ¿patient noted to have some drainage coming from the periumbilical site.Patient was also noted to have a circular mesh in the wound.This was dissected free from all surrounding tissues and when mobilizing on the left side there was noted to be a small bowel loop which was firmly adherent to the mesh and on freeing this, a small enterotomy.This was closed using sutures.The ventralex mesh (device 1) was completely removed.¿ on (b)(6) 2015 ¿ patient was diagnosed with ventral incisional hernia thereby underwent open repair with implant of xenmatrix surgical graft (device 2).Per operative notes, ¿the hernia defect and the sac was dissected free.Adhesions were lysed.The small bridge between the hernia defects was then divided to create one hernia defect.For the repair of the hernia, a xenmatrix surgical graft (device 2) was placed in the inner side of the anterior abdominal wall and tacked to the abdominal wall.¿ on (b)(6) 2015 ¿ patient was diagnosed with enterocutaneous fistula thereby underwent open repair with partial removal of xenmatrix surgical graft (device 2).Per operative notes, ¿the fistula was noted in the vertical incision, and this was extended down until a small cavity was obtained and this was noted to be going around a previously placed xenmatrix surgical graft.Some of the mesh which was involved in the cavity was excised (device 2) and fistula was removed.Adhesions were excised.¿ on (b)(6) 2017 ¿ patient was diagnosed with recurrent ventral incisional hernia thereby underwent robotic repair.(note: there is no op notes provided for this procedure).
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.This supplemental emdr represents the xenmatrix (device 2).An additional supplemental emdr was submitted to represent the bard/davol ventralex mesh (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 ; 8005566756
• MDR Report Key: 23787640
• Report Number: 1213643-2025-01191
• Device Sequence Number: 5546335
• Product Code: FTM
• UDI-Device Identifier: 00801741031380
• UDI-Public: (01)00801741031380
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2025

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: 1161015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 12/12/2025
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female