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

Catalog Number	1152025
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Necrosis (1971); Seroma (2069); Post Operative Wound Infection (2446)
Date of Event	12/29/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2010: patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of bard flat mesh (device 1).Per operative notes, ¿in the midline, three discrete defects in a row were noted and connected.The fascia was closed with sutures and bard flat mesh (device 1) was placed over the defect and secured with sutures.¿ (b)(6) 2016: patient was diagnosed with recurrent incarcerated ventral hernia thereby underwent open repair with partial removal of prior mesh (device 1) and implant of xenmatrix ab mesh (device 2) and phasix mesh (device 3).Per operative notes, ¿in the midline, the prior mesh (device 1) was hardened and fill the ventral hernia.Adhesions were lysed and hernia one above and below the bellybutton were reduced.The prior mesh (device 1) was partially removed and abscess was drained.The xenmatrix ab mesh (device 2) was placed over the fascia and reapproximated with sutures.The fascia was reinforced and phasix mesh (device 3) was placed and secured with sutures and optifix tackers.¿ (b)(6) 2016: patient was diagnosed with infected wound thereby underwent incision and drainage of infected wound and seroma.Per operative notes, ¿the infected seroma was drained, and fascia was irrigated and reapproximated with sutures.¿ (b)(6) 2016: patient was diagnosed with infected anterior abdominal wall wound thereby underwent open repair with removal of prior infected meshes (device 1, 2 and 3).Per operative notes, ¿the necrotized tissues with meshes (device 1, 2 and 3) in anterior abdominal wall were grasped from edges and removed.The area was irrigated and wound vac 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-apr-2016) is considered to be a best estimate.This mdr represents the xenmatrix ab mesh (device 2).An additional supplemental emdr was submitted to represent the bard flat mesh (device 1).An additional mdr was submitted to represent the phasix 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: 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: 24454606
• Report Number: 1213643-2026-00221
• Device Sequence Number: 18634167
• Product Code: PIJ
• UDI-Device Identifier: 00801741074288
• UDI-Public: (01)00801741074288(17)180428(10)HUAR0223
• Combination Product (Y/N): Y
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K151177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2026

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: 04/28/2018
• Device Catalogue Number: 1152025
• Device Lot Number: HUAR0223
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2016
• 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: 51 YR
• Patient Sex: Female