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

Catalog Number	1151520
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Adhesion(s) (1695); Bacterial Infection (1735); Pain (1994); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	07/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2014 - patient was diagnosed with ventral hernia thereby underwent open repair with the implant of ventralex st mesh (device 1).Per op notes, "a supraumbilical incision was made, a ventralex st mesh (device 1) was placed into the hernia defect using prolene sutures." on (b)(6) 2015 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the implant of synthetic mesh.Per op notes, "there was noted to be the old mesh at the level of the umbilicus and on the scar tissue, the scar was excised.Then a synthetic mesh was placed." on (b)(6) 2017 - patient underwent excision of the abdominal wall scar.On (b)(6) 2017 - patient was diagnosed with chronic abdominal wall infection and adhesions thereby underwent repair with removal of ventralex st mesh (device 1) and synthetic mesh and implant of xenmatrix ab (device 2).(notes: no op notes were provided).On (b)(6) 2019 - patient was diagnosed with recurrent incisional hernia thereby underwent repair removal of mesh (device 2).Per op notes, "included with hernia sac the old xenmatrix ab (device 2) which had ballooned into the defect and was adherent to the hernia sac itself and was removed.The mesh that was removed showed mrsa involvement.Patient also had issues with a bowel obstruction and also had a constant pain.Then a synthetic mesh was placed.".
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-nov-2016) is considered to be a best estimate.This emdr represents the xenmatrix ab (device 2).An additional supplemental emdr was submitted to represent the ventralex st (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 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: 50588119
• Report Number: 1213643-2026-01150
• Device Sequence Number: 13124479
• Product Code: FTM
• UDI-Device Identifier: 00801741074240
• UDI-Public: (01)00801741074240(17)181028(10)HUAY0406
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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: 10/28/2018
• Device Catalogue Number: 1151520
• Device Lot Number: HUAY0406
• 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: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2016
• 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