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

Catalog Number	1161015
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Abdominal Pain (1685); Scar Tissue (2060); Hernia (2240)
Date of Event	07/18/2019
Type of Reportable Event	Serious Injury
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 st mesh (device 1).Note, the manufacturing date (15-sep-2016) is considered to be a best estimate.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.
Event or Problem Description
Per information provided: on (b)(6) 2013 ¿ patient was diagnosed with ventral hernia thereby underwent open repair with implant of ventralex st mesh (device 1).Per operative notes, "an upper abdominal ventral hernia was noted.The hernia sac was reduced all the way down to the fascia and removed.A large ventralex st mesh (device 1) was placed over the defect and sutured in underlay fashion with sutures.The fascial defect was closed and secured with sutures and staples." on (b)(6) 2017 - patient was diagnosed with recurrent ventral hernia with chronic pain thereby underwent open repair with implant of xenmatrix mesh (device 2) and removal of prior mesh (device 1).Per operative notes, through the prior incision, the upper abdominal midline mesh (device 1) was seen firm and excised from the subcutaneous tissues and overlying scar tissues.Multiple titanium tacks were also removed.The recurrent fascial defect in the midline in supraumbilical area was removed and flaps were raised.The fascia was closed and secured with sutures.A xenmatrix mesh (device 2) was placed over the fascia and secured with sutures to the anterior abdominal wall." on (b)(6) 2019 - patient was diagnosed with recurrent ventral incisional hernia, chronic upper abdominal pain, retained mesh (device 2) and surgical tacks thereby underwent open repair with implant of phasix flat mesh (device 3) and removal of retained xenmatrix mesh (device 2).Per operative notes, "through the prior surgical scar in upper abdomen, the xenmatrix mesh (device 2) that was firm, thickened and slightly contracted was noted and dissected entirely.The retained synthetic surgical tacks were also removed.The defect in the posterior fascia was reduced, and phasix flat mesh (device 3) was placed and secured with sutures.The fascia was closed over the top of the mesh (device 3) and sutured.".

• 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: 24764656
• Report Number: 1213643-2026-00426
• Device Sequence Number: 18709186
• Product Code: FTM
• UDI-Device Identifier: 00801741031380
• UDI-Public: (01)00801741031380(17)180828(10)HUAW1166
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K140501
• 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): 03/24/2026

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: 08/28/2018
• Device Catalogue Number: 1161015
• Device Lot Number: HUAW1166
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2016
• 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 Age: 41 YR
• Patient Sex: Male
• Patient Weight: 76 KG