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	Necrosis (1971); Seroma (2069); Wound Infection (2447)
Date of Event	10/12/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2010 - patient was diagnosed with ventral hernia thereby underwent open repair with implant of ventralex mesh (device 1).Per operative notes, ¿a vertical incision was made over the supraumbilical midline over the hernia mass.The hernia sac was removed.A ventralex mesh (device 1) was placed into the abdomen and secure it with sutures.¿ (b)(6) 2011 - patient was diagnosed with wound infection, scar tissue thereby underwent open repair with exploration and debridement of wound.Per operative notes, ¿a vertical incision was made in the umbilicus.Previously placed mesh was well incorporated.Scar tissue was removed.Wound was irrigated.Vac placement was done for wound.¿ (b)(6) 2012 ¿ patient was diagnosed with recurrent ventral hernia; chronic wound infection, scar tissue thereby underwent open repair with explant of ventralex mesh (device 1) and implant of xenmatrix mesh (device 2).Per operative notes, ¿the prior hernia site was identified in the periumbilical area.The old scar was identified and removed entirely.The hernia sac was dissected out.Previously placed ventralex mesh (device 1) was removed.Chronic drainage was done from the wound.Vac placement was done.A xenmatrix mesh (device 2) was placed into the defect and sutured.¿ (b)(6) 2012 - patient was diagnosed with wound infection, necrosis, seroma thereby underwent repair with wound exploration and placement of wound vac.Per operative notes, ¿the prior vertical incision was identified, and it was draining material.Previously placed xenmatrix mesh (device 2) was intact.There was free floating brownish fluid, and it was taken as well as completely suctioned off the field.A little bit of necrotic tissue from the cavity was debrided sharply.Wound vac was placed and drainage was done.¿.
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 mdr represents the xenmatrix mesh (device 2).An additional supplemental emdr was submitted to represent the 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: 23941375
• Report Number: 1213643-2025-01295
• Device Sequence Number: 7875376
• Product Code: FTM
• UDI-Device Identifier: 00801741031380
• UDI-Public: (01)00801741031380
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K140501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/31/2025

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: 12/10/2025
• Initial Report FDA Received Date: 01/02/2026
• 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: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male