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

Catalog Number	1151015
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Abdominal Pain (1685); Necrosis (1971)
Date of Event	11/07/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2012 ¿ patient was diagnosed with incarcerated incisional hernia thereby underwent laparoscopic repair with the implant of sepramesh ip (device 1).Per op notes, ¿the large chronic hernia sac was excised.There was a separate hernia near the umbilicus from chronic incision.The sepramesh ip (device 1) was placed to cover all the defects and fascia was closed primarily using sutures.Then the mesh was tacked all around the edge and hernia itself using protacks.¿ (b)(6) 2017 ¿ patient had pain and was diagnosed with recurrent incisional hernia, abscess, infected mesh thereby underwent open repair with the removal of mesh (device 1) and implant of xenmatrix ab (device 2).Per op notes, ¿the abscess cavity full of gross pus was suctioned out.In cavity, sutures and mesh was noted.Adhesion was taken down.The mesh (device 1) was removed and fascial defect was encountered.A piece of xenmatrix ab (device 2) was placed as underlay to repair the defect and anchored to fascia with suture.The mesh was tacked circumferentially to anterior abdominal wall.¿ 07-nov-2017 ¿ patient had abdominal pain and was diagnosed with necrotic open abdominal wound thereby underwent excisional wound debridement.Per op notes, ¿the lateral side of wound was dissected and entire wound was removed en bloc.¿.
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-feb-2017) is considered to be a best estimate.This mdr represents the xenmatrix ab (device 2).An additional supplemental emdr was submitted to represent the sepramesh ip (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 ; 8005566756
• MDR Report Key: 24321655
• Report Number: 1213643-2026-00115
• Device Sequence Number: 9912300
• Product Code: PIJ
• UDI-Device Identifier: 00801741074226
• UDI-Public: (01)00801741074226(17)190228(10)HUBP1198
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2026

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: 02/28/2019
• Device Catalogue Number: 1151015
• Device Lot Number: HUBP1198
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2017
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 98 KG