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

Catalog Number	1152020
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Unspecified Infection (1930); Seroma (2069); Impaired Healing (2378)
Date of Event	04/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As per patient advocate: ni/ni/ni - the patient had a small bowel obstruction and underwent surgery which included creation of an ileostomy.On (b)(6) 2021- the patient underwent an ileostomy reversal and abd wall reconstruction procedure with implant of a xenmatrix ab graft (device #1).Post implant the patient experienced wound healing issues, seromas, infections and was treated with wound care and antibiotics.On (b)(6) 2022- the patient was diagnosed with a ventral hernia and underwent repair with implant of the phasix mesh (device #2).On (b)(6) 2022 - the patient was diagnosed with an incarcerated incisional hernia and underwent repair with the implant of a soft mesh (device #3).As reported, the patient has not had any of the meshes removed.As reported, patient experienced multiple post operative complications including wound healing issues and chronic abdominal pain.Patient has had multiple epidural injections and had a pain stimulator with no relief.Reportedly, the patient is currently experiencing "inflammation in her gut and swelling in her left leg." patient has seen at least 4 different gastroenterologists for her gastrointestinal issues, had been diagnosed with a pancreas and kidney cysts which continue to be monitored.The patient has been referred to an allergist for evaluation and possible reactivity testing.This file represents device #1 (xenmatrix ab mesh).
Additional Manufacturer Narrative
Based on the information provided, no determination can be made regarding the degree to which the xenmatrix ab implant used to treat the patient may have caused or contributed to the patient's postoperative course.The adverse reactions section of the instructions for use (ifu) supplied with the device identifies seroma and infection as known potential complications associated with use of the product.A review of the manufacturing records was conducted and confirmed that the product was manufactured in accordance with established specifications.To date, this is the only reported complaint associated with this manufacturing lot of 37 units distributed.Note, the date of event (07-apr-2021) is considered to be a best estimate.This mdr represents the xenmatrix ab (device #1).Additional mdrs were submitted to represent the phasix mesh (device #2) and soft mesh (device #3).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 AB
• 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: 50021379
• Report Number: 1213643-2026-00944
• Device Sequence Number: 16080724
• Product Code: PIJ
• UDI-Device Identifier: 00801741074295
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K151177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2026

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: 05/28/2021
• Device Catalogue Number: 1152020
• Device Lot Number: HUDS1116
• 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: 06/29/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2019
• 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: Female