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

Catalog Number	1151928
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abscess (1690); Purulent Discharge (1812); Pain (1994)
Date of Event	04/23/2020
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 mesh (device 3).Additional supplemental emdr's were submitted to represent the bard flat mesh (device 1), bard flat mesh (device 2).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: (b)(6) 2000- patient was diagnosed with giant ventral incisional hernia, thereby underwent open repair with implant of bard flat mesh (device 1).Per op notes, ¿the hernia was identified in right upper quadrant.A bard flat mesh was attached to fascia of left upper quadrant and right upper quadrant and sutured¿.(b)(6) 2002- patient was diagnosed with recurrent ventral hernia thereby underwent open repair.Per op notes, ¿the bard flat mesh (device 1) was identified to be loosen from the lateral abdominal wall.A hernia with omentum was identified in the right lateral abdominal region.The bard flat mesh (device 1) was sutured to the lateral abdominal wall¿.(note: there is no indication in the medical records provided that the patient was implanted with a bard flat mesh (device 2) during this repair) (b)(6) 2019- patient was diagnosed with enterocutaneous fistula, thereby underwent open repair with partial explant of bard flat mesh (device 1).Per op notes, ¿the small intestine was adherent to previously placed mesh of the abdominal wall, which resulted in the enterocutaneous fistula.Severe adhesions were also noted with the bard flat mesh and was lysed.The fistula, adhesions and the bard flat mesh (device 1) were resected.¿ (b)(6) 2020- patient was diagnosed with recurrent enterocutaneous fistula, infected abdominal wall mesh, recurrent ventral incisional hernia, thereby underwent open repair with explant of bard flat mesh (device 1) and implant of xenmatrix ab mesh (device 3).Per op notes, ¿adhesions were noted with the bard flat mesh (device 1) where the adhesions were lysed and the mesh was explanted.A large ventral incisional hernia was noted and a xenmatrix ab mesh (device 3) was trimmed and placed on the defect and sutured.Then a synthetic mesh was placed overlay for second layer of mesh and sutured¿.(b)(6) 2020- patient was diagnosed with abdominal wall abscess with pain and purulent drainage, thereby underwent open repair.Per op notes, ¿the xenmatrix ab mesh (device 3) was exposed and abscess was identified in the abdominal region and was drained¿.

• 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 ; 8005566756
• MDR Report Key: 24002476
• Report Number: 1213643-2026-00007
• Device Sequence Number: 18774264
• Product Code: PIJ
• UDI-Device Identifier: 00801741074271
• UDI-Public: (01)00801741074271
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K133223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2026

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 Catalogue Number: 1151928
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 01/08/2026
• 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: 49 YR
• Patient Sex: Male