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

Catalog Number	1151520
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Scar Tissue (2060); Hernia (2240)
Date of Event	07/30/2020
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 ab (device 2).An additional supplemental emdr was submitted to represent the ventralex mesh (device 1).Note, the manufacturing date (15-jan-2018) 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) 2012 - patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic converted to open repair with implant of ventralex mesh (device 1).Per op notes, ¿the old mesh was noted retracted and curled over was excised.The hernia sac was noted and excised.A ventralex mesh (device 1) was placed and sutured.¿ on (b)(6) 2014 - patient was diagnosed with incarcerated recurrent ventral hernia and obstruction thereby underwent open repair.Per op notes, ¿the defect from the previous mesh was noted and the contents of hernia defect was reduced and excised.The old mesh (device 1) was well incorporated and difficult to explant.The hernia defect was repaired primarily with sutures.¿ on (b)(6) 2019 - patient was diagnosed with abdominal pain and infected mesh thereby underwent open repair with excision of ventralex mesh (device 1).Per op notes, ¿midline incision was made.Significant adhesions between small bowel and the old mesh were lysed.The recurrent hernia defect was noted just lateral to the old mesh.Some serous fluid collection above the mesh were drained.The mesh (device 1) was excised entirely.Component separation was performed.The hernia defect was repaired primarily with sutures.¿ on (b)(6) 2019 - patient was diagnosed with incisional hernia thereby underwent open repair with implant of xenmatrix ab (device 2).Per op notes, ¿incision was made on previous laparotomy site.The hernia sac was identified and reduced.A xenmatrix ab (device 2) was placed and sutured circumferentially.¿ on (b)(6) 2020 - patient was diagnosed with recurrent incisional ventral hernia thereby underwent open repair with excision of xenmatrix ab (device 2) and implant of xenmatrix ab (device 3).Per op notes, ¿prior scar was opened.Old xenmatrix mesh (device 2) was in noted and excised entirely.The hernia sac was noted and dissected free.A xenmatrix ab (device 3) was placed and secured using sutures.¿.

• Brand Name: XENMATRIX AB
• Common Device Name: 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: 25299807
• Report Number: 1213643-2026-00678
• Device Sequence Number: 9367988
• Product Code: PIJ
• UDI-Device Identifier: 00801741074240
• UDI-Public: (01)00801741074240(17)200328(10)HUCN1725
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K133223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2026

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: 03/28/2020
• Device Catalogue Number: 1151520
• Device Lot Number: HUCN1725
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2018
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 82 KG